Arthroplasty system and related methods

ABSTRACT

A method of manufacturing an arthroplasty jig is disclosed herein. The method may include the following: generate a bone model, wherein the bone model includes a three dimensional computer model of at least a portion of a joint surface of a bone of a patient joint to undergo an arthroplasty procedure; generate an implant model, wherein the implant model includes a three dimensional computer model of at least a portion of a joint surface of an arthroplasty implant to be used in the arthroplasty procedure; assess a characteristic associated with the patient joint; generate a modified joint surface of the implant model by modifying at least a portion of a joint surface of the implant model according to the characteristic; and shape match the modified joint surface of the implant model and a corresponding joint surface of the bone model.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of U.S. applicationSer. No. 12/563,809 filed Sep. 21, 2009 (“the '809 application), whichapplication claims priority to U.S. Patent Application 61/102,692 (“the'692 application”) which was filed Oct. 3, 2008 and entitledArthroplasty System and Related Methods. The '809 application is alsocontinuation-in-part (“CIP”) application of U.S. patent application Ser.No. 11/959,344, which was filed Dec. 18, 2007, now U.S. Pat. No.8,221,430, and entitled System and Method for Manufacturing ArthroplastyJigs. The '809 application is also a CIP application of U.S. patentapplication Ser. No. 12/111,924 (“the '924 application”), which wasfiled Apr. 29, 2008, now U.S. Pat. No. 8,480,679, and entitledGeneration of a Computerized Bone Model Representative of aPre-Degenerated State and Useable in the Design and Manufacture ofArthroplasty Devices. The '809 application is also a CIP application ofU.S. patent application Ser. No. 12/505,056 (“the '056 application”),which was filed Jul. 17, 2009 and entitled System and Method forManufacturing Arthroplasty Jigs Having Improved Mating Accuracy. The'056 application claims priority to U.S. Patent Application 61/083,053filed Jul. 23, 2008 and entitled System and Method for ManufacturingArthroplasty Jigs Having Improved Mating Accuracy. The presentapplication claims priority to all of the above-mentioned applicationsand hereby incorporates by reference all of the above-mentionedapplications in their entireties into the present application.

FIELD OF THE INVENTION

The present invention relates to systems and methods for manufacturingcustomized arthroplasty cutting jigs. More specifically, the presentinvention relates to automated systems and methods of manufacturing suchjigs.

BACKGROUND OF THE INVENTION

Over time and through repeated use, bones and joints can become damagedor worn. For example, repetitive strain on bones and joints (e.g.,through athletic activity), traumatic events, and certain diseases(e.g., arthritis) can cause cartilage in joint areas, which normallyprovides a cushioning effect, to wear down. When the cartilage wearsdown, fluid can accumulate in the joint areas, resulting in pain,stiffness, and decreased mobility.

Arthroplasty procedures can be used to repair damaged joints. During atypical arthroplasty procedure, an arthritic or otherwise dysfunctionaljoint can be remodeled or realigned, or an implant can be implanted intothe damaged region. Arthroplasty procedures may take place in any of anumber of different regions of the body, such as a knee, a hip, ashoulder, or an elbow.

One type of arthroplasty procedure is a total knee arthroplasty (“TKA”),in which a damaged knee joint is replaced with prosthetic implants. Theknee joint may have been damaged by, for example, arthritis (e.g.,severe osteoarthritis or degenerative arthritis), trauma, or a raredestructive joint disease. During a TKA procedure, a damaged portion inthe distal region of the femur may be removed and replaced with a metalshell, and a damaged portion in the proximal region of the tibia may beremoved and replaced with a channeled piece of plastic having a metalstem. In some TKA procedures, a plastic button may also be added underthe surface of the patella, depending on the condition of the patella.

Implants that are implanted into a damaged region may provide supportand structure to the damaged region, and may help to restore the damagedregion, thereby enhancing its functionality. Prior to implantation of animplant in a damaged region, the damaged region may be prepared toreceive the implant. For example, in a knee arthroplasty procedure, oneor more of the bones in the knee area, such as the femur and/or thetibia, may be treated (e.g., cut, drilled, reamed, and/or resurfaced) toprovide one or more surfaces that can align with the implant and therebyaccommodate the implant.

Accuracy in implant alignment is an important factor to the success of aTKA procedure. A one- to two-millimeter translational misalignment, or aone- to two-degree rotational misalignment, may result in imbalancedligaments, and may thereby significantly affect the outcome of the TKAprocedure. For example, implant misalignment may result in intolerablepost-surgery pain, and also may prevent the patient from having full legextension and stable leg flexion.

To achieve accurate implant alignment, prior to treating (e.g., cutting,drilling, reaming, and/or resurfacing) any regions of a bone, it isimportant to correctly determine the location at which the treatmentwill take place and how the treatment will be oriented. In some methods,an arthroplasty jig may be used to accurately position and orient afinishing instrument, such as a cutting, drilling, reaming, orresurfacing instrument on the regions of the bone. The arthroplasty jigmay, for example, include one or more apertures and/or slots that areconfigured to accept such an instrument.

A system and method has been developed for producing customizedarthroplasty jigs configured to allow a surgeon to accurately andquickly perform an arthroplasty procedure that restores thepre-deterioration alignment of the joint, thereby improving the successrate of such procedures. Specifically, the customized arthroplasty jigsare indexed such that they matingly receive the regions of the bone tobe subjected to a treatment (e.g., cutting, drilling, reaming, and/orresurfacing). The customized arthroplasty jigs are also indexed toprovide the proper location and orientation of the treatment relative tothe regions of the bone. The indexing aspect of the customizedarthroplasty jigs allows the treatment of the bone regions to be donequickly and with a high degree of accuracy that will allow the implantsto restore the patient's joint to a generally pre-deteriorated state.However, the system and method for generating the customized jigs oftenrelies on a human to “eyeball” bone models on a computer screen todetermine configurations needed for the generation of the customizedjigs. This “eyeballing” or manual manipulation of the bone modes on thecomputer screen is inefficient and unnecessarily raises the time,manpower and costs associated with producing the customized arthroplastyjigs. Furthermore, a less manual approach may improve the accuracy ofthe resulting jigs.

There is a need in the art for a system and method for reducing thelabor associated with generating customized arthroplasty jigs. There isalso a need in the art for a system and method for increasing theaccuracy of customized arthroplasty jigs.

SUMMARY

Various embodiments of a method of manufacturing an arthroplasty jig aredisclosed herein. In a first embodiment, the method may include thefollowing: generate a bone model, wherein the bone model includes athree dimensional computer model of at least a portion of a jointsurface of a bone of a patient joint to undergo an arthroplastyprocedure; generate an implant model, wherein the implant model includesa three dimensional computer model of at least a portion of a jointsurface of an arthroplasty implant to be used in the arthroplastyprocedure; assess a characteristic associated with the patient joint;generate a modified joint surface of the implant model by modifying atleast a portion of a joint surface of the implant model according to thecharacteristic; and shape match the modified joint surface of theimplant model and a corresponding joint surface of the bone model.

In a second embodiment, the method may include the following: generate arestored bone model, wherein the bone model includes a three dimensionalcomputer model of at least a portion of a joint surface of a bone of apatient joint to undergo an arthroplasty procedure, wherein the restoredbone model is representative of the bone in a pre-degenerated state;generate an implant model, wherein the implant model includes a threedimensional computer model of at least a portion of a joint surface ofan arthroplasty implant to be used in the arthroplasty procedure; andshape match an articular joint surface of the restored bone model and acorresponding articular joint surface of the implant model.

In a third embodiment, the method may include the following: generate abone model, wherein the bone model includes a three dimensional computermodel of at least a portion of a knee joint surface of a patient femurto undergo an arthroplasty procedure; identify at least one of a mostdistal point and a most posterior point of a condyle articular surfaceof the bone model; generate an implant model, wherein the implant modelincludes a three dimensional computer model of at least a portion of ajoint surface of a femoral arthroplasty knee implant to be used in thearthroplasty procedure; identify at least one of a most distal point anda most posterior point of a condyle articular surface of the implantmodel; and move at least one of the bone model and the implant model sothe at least one of the most distal point and the most posterior pointof the condyle articular surface of the bone model generallypositionally correspond with the at least one of the most distal pointand the most posterior point of the condyle articular surface of theimplant model. In a variation of the third embodiment, the method mayfurther include the following: shape match the condyle articular surfaceof the bone model and the articular condyle surface of the implantmodel.

In a fourth embodiment, the method may include the following: generatetwo-dimensional images of a joint surface of a patient bone; generatefirst data from the two-dimensional images, wherein the first data isrepresentative of the joint surface in a deteriorated state; generatesecond data from the two-dimensional images, wherein the second data isrepresentative of the joint surface in a non-deteriorated state;generate third data and fourth data positionally referenced to the thirddata, wherein the third data is representative of a joint surface of anarthroplasty implant and the fourth data is representative of a surgicalcut plane associated with the arthroplasty implant; generate fifth datafrom the first data, wherein the fifth data is representative of asurface of the arthroplasty jig that will matingly receive the jointsurface; generate sixth data by matching the second data and the thirddata, the resulting sixth data including a position of the fourth datawhen the second and third data are matched; generate seventh data bymerging the fifth data and the sixth data; and employ the seventh datain manufacturing the arthroplasty jig from a jig blank.

An arthroplasty jig is also disclosed herein. In one embodiment, thearthroplasty jig may be for performing an arthroplasty procedure on ajoint surface of a bone of a patient joint to receive an arthroplastyjoint implant. In one embodiment, the arthroplasty jig may include: amating surface configured to matingly receive the joint surface; a firstsaw guide oriented relative to the mating surface to result in aresection that allows the arthroplasty joint implant to restore thepatient joint to a pre-degenerated alignment; and a second saw guideoriented relative to the mating surface to result in a resection thatallows the arthroplasty joint implant to cause the patient joint to havean alignment approaching a zero degree mechanical axis alignment.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram of a system for employing the automatedjig production method disclosed herein.

FIGS. 1B-1E are flow chart diagrams outlining the jig production methoddisclosed herein.

FIGS. 1F and 1G are, respectively, bottom and top perspective views ofan example customized arthroplasty femur jig.

FIGS. 1H and 1I are, respectively, bottom and top perspective views ofan example customized arthroplasty tibia jig.

FIGS. 1J and 1K contain portions of a flow chart illustrating anoverview of the POP system and method disclosed herein.

FIG. 2A is an isometric view of a 3D computer model of a femur lower endand a 3D computer model of a tibia upper end in position relative toeach to form a knee joint and representative of the femur and tibia in anon-degenerated state.

FIG. 2B is an isometric view of a 3D computer model of a femur implantand a 3D computer model of a tibia implant in position relative to eachto form an artificial knee joint.

FIG. 3A is a plan view of the joint side of the 3D femur implant modeldepicted in FIG. 2B.

FIG. 3B is an axial end view of the lower end of the 3D computer modelof the femur depicted in FIG. 2A and showing the condoyle surfaces.

FIG. 3C is a flow chart depicting the process undertaken by the systemwhen selecting the appropriate femur implant size.

FIG. 3D is a plan view of the joint side of the 3D tibia implant modeldepicted in FIG. 2B.

FIG. 3E is an axial end view of the upper end of the 3D computer modelof the tibia depicted in FIG. 2A and showing the plateau.

FIG. 3F is a flow chart depicting the process undertaken by the systemwhen selecting the appropriate tibia implant size.

FIG. 4A shows the restored bone models depicted in FIG. 2A positionedaway from the implant models depicted in FIG. 2B, but being movedtowards the implant models.

FIG. 4B is an isometric view of the femur and tibia restored bone modelssuperimposed over the femur and tibia implant models.

FIG. 4C is a flow chart depicting the process undertaken by the systemwhen moving the femur and tibia restored bone models to be superimposedover the femur and tibia implant models.

FIG. 5A is a view of the lateral side of the lower or distal portion ofthe femur restored bone model illustrating how to determine landmarkreference lines for the posterior and anterior sides of the femurrestored bone model.

FIG. 5B is an anterior or coronal view of FIG. 5A illustrating how todetermine landmark reference lines for the medial and lateral sides ofthe femur restored bone model.

FIG. 5C is a flow chart illustrating the process for determining thelandmark references.

FIG. 5D is a sagittal view of a femur restored bone model illustratingthe orders and orientations of imaging slices forming the femur restoredbone model.

FIG. 5E is the distal images slices taken along section lines of thefemur restored bone model in FIG. 5D.

FIG. 5F is the coronal images slices taken along section lines of thefemur restored bone model in FIG. 5D.

FIG. 5G is a perspective view of the distal end of the femur restoredbone model.

FIGS. 6A and 6B are respective sagittal views of the lateral and medialcondyles of the femur restored bone model depicted in FIG. 5B, whereinelliptical contours of the condyles have been determined from thelandmark reference lines depicted in FIG. 5B.

FIG. 6C is a flow chart illustrating the process of determining theelliptical contours of the condyles from the landmark reference linesdepicted in FIG. 5B.

FIG. 7A shows an isometric bottom view of the conventional femoralimplant model depicted in FIG. 2B.

FIGS. 7B and 7C are, respectively, side views of the lateral and medialsides of the femur implant model depicted in FIG. 7A.

FIG. 7D is a flow chart illustrating the method of determiningelliptical contours and aligning respective condyles.

FIG. 8A shows a coronal view of a distal femur restored bone modelhaving an asymmetrical relationship between its condyles.

FIG. 8B shows a coronal view of a distal femur restored model havingsymmetrical femoral condyles.

FIGS. 9A and 9B are, respectively, an isometric view of a symmetricfemur implant model and a lateral side view of the femur implant modelafter being asymmetrically modified.

FIG. 9C is a flow chart depicting the method of shape fitting with anasymmetrically modified femur implant model.

FIG. 10 is a coronal view of the femur restored bone model and theasymmetrical implant model aligned along the FAA, which serves as thereference axis for rotational and translation alignment between thefemur and implant models.

FIG. 11A is a coronal view of the asymmetrical femur restored bone modeland the symmetrical implant model.

FIG. 11B is a flow chart illustrating the method of shape fitting withthe symmetrical implant model.

FIG. 12 shows the sagittal view MRI slice of the femoral condyle and theproximal tibia of the knee in a MRI image slice.

FIG. 13 is a coronal view of a knee model in extension.

FIGS. 14A and 14B illustrate MRI segmentation slices for joint lineassessment.

FIG. 14C is a flow chart illustrating the method for determiningcartilage thickness used to determine proper joint line.

FIG. 14D illustrates a MRI segmentation slice for joint line assessment.

FIGS. 14E and 14F illustrate coronal views of the restored bone modelsin their alignment relative to each as a result of OA.

FIG. 14G illustrates a coronal view of the restored bone models with arestored gap Gp3.

FIG. 14H is a coronal view of restored bone models oriented relative toeach other in a deteriorated state orientation.

FIGS. 15A and 15B are, respectively, an isometric view and a lateralside view of the modified femoral implant model.

FIG. 16 is an isometric view of a femoral implant model being shapematched to a femur restored bone model.

FIGS. 17A and 17B are isometric views of an ellipsoid model of a femoralcondyle obtained through a plurality of MRI slices taken in a mannersimilar to the MRI slice depicted in FIG. 12 and from areas A and B inFIG. 13.

FIG. 18 is an isometric view depicting the 3D surface matching using thecondyle models of FIGS. 17A and 17B.

FIG. 19A shows the sagittal view of inaccurate rotation alignmentbetween the anterior flange of femoral implant model and the anteriorportion of the femur restored bone model.

FIG. 19B shows the sagittal view of correct rotation alignment betweenthe anterior flange of the femoral implant model and the anteriorportion of the femur restored bone model.

FIG. 20 is a plan or top view of the plateau of the tibia restored bonemodel.

FIG. 21A is a MRI image slice of the medial portion of the proximaltibia and indicates the establishment of landmarks for the tibia POPdesign.

FIG. 21B is a MRI image slice of the lateral portion of the proximaltibia.

FIG. 21C as an isometric view of the tibia implant model.

FIGS. 22A and 22B are, respectively, lateral and medial sagittal MRIviews of the plateau of the tibia.

FIGS. 23A-23C are, respectively, two isometric views and a side view ofthe tibia implant model.

FIGS. 24A and 24B, which are, respectively, a plan or top view of thetibia plateau and a side medial side view of the tibia restored bonemodel.

FIG. 25 is an isometric view of the tibia implant model as it iscompensated to account for the adjustment value tr.

FIG. 26 is an isometric view of the tibia implant model being surfacematched relative to the tibia restored bone model.

FIGS. 27A and 27B are, respectively, medial and lateral sagittal MRIviews of the tibia.

FIG. 28 is an isometric view of the tibia restored bone model and tibiaimplant model being used in the surface matching process.

FIG. 29A is an isometric view of the tibia restored bone model showingthe surgical cut plane design.

FIGS. 29B and 29C are sagittal MRI views of the surgical tibia cut planedesign with the PCL.

FIGS. 30A-30C are various views of the implant models superimposed onthe restored bone models.

FIG. 30D is a coronal view of the restored bone models.

FIGS. 31A-32B illustrate isometric views of embodiments of thearthroplasty jigs configured to provide natural alignment resections,zero degree mechanical axis alignment resections, and resectionsresulting in alignments between zero degree mechanical axis alignmentand natural alignment.

DETAILED DESCRIPTION

Disclosed herein are customized arthroplasty jigs 2 and systems 4 for,and methods of, producing such jigs 2. The jigs 2 are customized to fitspecific bone surfaces of specific patients. Depending on the embodimentand to a greater or lesser extent, the jigs 2 are automatically plannedand generated and may be similar to those disclosed in these three U.S.patent applications: U.S. patent application Ser. No. 11/656,323 to Parket al., titled “Arthroplasty Devices and Related Methods” and filed Jan.19, 2007; U.S. patent application Ser. No. 10/146,862 to Park et al.,titled “Improved Total Joint Arthroplasty System” and filed May 15,2002; and U.S. patent Ser. No. 11/642,385 to Park et al., titled“Arthroplasty Devices and Related Methods” and filed Dec. 19, 2006. Thedisclosures of these three U.S. patent applications are incorporated byreference in their entireties into this Detailed Description.

A. Overview of System and Method for Manufacturing CustomizedArthroplasty Cutting Jigs

For an overview discussion of the systems 4 for, and methods of,producing the customized arthroplasty jigs 2, reference is made to FIGS.1A-1E.

FIG. 1A is a schematic diagram of a system 4 for employing the automatedjig production method disclosed herein. FIGS. 1B-1E are flow chartdiagrams outlining the jig production method disclosed herein. Thefollowing overview discussion can be broken down into three sections.

The first section, which is discussed with respect to FIG. 1A and[blocks 100-125] of FIGS. 1B-1E, pertains to an example method ofdetermining, in a three-dimensional (“3D”) computer model environment,saw cut and drill hole locations 30, 32 relative to 3D computer modelsthat are termed restored bone models 28. The resulting “saw cut anddrill hole data” 44 is referenced to the restored bone models 28 toprovide saw cuts and drill holes that will allow arthroplasty implantsto restore the patient's joint to its pre-degenerated or naturalalignment state.

The second section, which is discussed with respect to FIG. 1A and[blocks 100-105 and 130-145] of FIGS. 1B-1E, pertains to an examplemethod of importing into 3D computer generated jig models 38 3D computergenerated surface models 40 of arthroplasty target areas 42 of 3Dcomputer generated arthritic models 36 of the patient's joint bones. Theresulting “jig data” 46 is used to produce a jig customized to matinglyreceive the arthroplasty target areas of the respective bones of thepatient's joint.

The third section, which is discussed with respect to FIG. 1A and[blocks 150-165] of FIG. 1E, pertains to a method of combining orintegrating the “saw cut and drill hole data” 44 with the “jig data” 46to result in “integrated jig data” 48. The “integrated jig data” 48 isprovided to the CNC machine 10 or other rapid production machine (e.g.,a stereolithography apparatus (“SLA”) machine) for the production ofcustomized arthroplasty jigs 2 from jig blanks 50 provided to the CNCmachine 10. The resulting customized arthroplasty jigs 2 include saw cutslots and drill holes positioned in the jigs 2 such that when the jigs 2matingly receive the arthroplasty target areas of the patient's bones,the cut slots and drill holes facilitate preparing the arthroplastytarget areas in a manner that allows the arthroplasty joint implants togenerally restore the patient's joint line to its pre-degenerated stateor natural alignment state.

As shown in FIG. 1A, the system 4 includes a computer 6 having a CPU 7,a monitor or screen 9 and an operator interface controls 11. Thecomputer 6 is linked to a medical imaging system 8, such as a CT or MRImachine 8, and a computer controlled machining system 10, such as a CNCmilling machine 10.

As indicated in FIG. 1A, a patient 12 has a joint 14 (e.g., a knee,elbow, ankle, wrist, hip, shoulder, skull/vertebrae orvertebrae/vertebrae interface, etc.) to be replaced. The patient 12 hasthe joint 14 scanned in the imaging machine 8. The imaging machine 8makes a plurality of scans of the joint 14, wherein each scan pertainsto a thin slice of the joint 14.

As can be understood from FIG. 1B, the plurality of scans is used togenerate a plurality of two-dimensional (“2D”) images 16 of the joint 14[block 100]. Where, for example, the joint 14 is a knee 14, the 2Dimages will be of the femur 18 and tibia 20. The imaging may beperformed via CT or MRI. In one embodiment employing MRI, the imagingprocess may be as disclosed in U.S. patent application Ser. No.11/946,002 to Park, which is entitled “Generating MRI Images Usable ForThe Creation Of 3D Bone Models Employed To Make Customized ArthroplastyJigs,” was filed Nov. 27, 2007 and is incorporated by reference in itsentirety into this Detailed Description.

As can be understood from FIG. 1A, the 2D images are sent to thecomputer 6 for creating computer generated 3D models. As indicated inFIG. 1B, in one embodiment, point P is identified in the 2D images 16[block 105]. In one embodiment, as indicated in [block 105] of FIG. 1A,point P may be at the approximate medial-lateral and anterior-posteriorcenter of the patient's joint 14. In other embodiments, point P may beat any other location in the 2D images 16, including anywhere on, nearor away from the bones 18, 20 or the joint 14 formed by the bones 18,20.

As described later in this overview, point P may be used to locate thecomputer generated 3D models 22, 28, 36 created from the 2D images 16and to integrate information generated via the 3D models. Depending onthe embodiment, point P, which serves as a position and/or orientationreference, may be a single point, two points, three points, a point plusa plane, a vector, etc., so long as the reference P can be used toposition and/or orient the 3D models 22, 28, 36 generated via the 2Dimages 16.

As shown in FIG. 1C, the 2D images 16 are employed to create computergenerated 3D bone-only (i.e., “bone models”) 22 of the bones 18, 20forming the patient's joint 14 [block 110]. The bone models 22 arelocated such that point P is at coordinates (X_(0-j), Y_(0-j), Z_(0-j))relative to an origin (X₀, Y₀, Z₀) of an X-Y-Z axis [block 110]. Thebone models 22 depict the bones 18, 20 in the present deterioratedcondition with their respective degenerated joint surfaces 24, 26, whichmay be a result of osteoarthritis, injury, a combination thereof, etc.

In one embodiment, the bone surface contour lines of the bones 18, 20depicted in the image slices 16 may be auto segmented via a imagesegmentation process as disclosed in U.S. Patent Application 61/126,102,which was filed Apr. 30, 2008, is entitled System and Method for ImageSegmentation in Generating Computer Models of a Joint to UndergoArthroplasty, and is hereby incorporated by reference into the presentapplication in its entirety.

Computer programs for creating the 3D computer generated bone models 22from the 2D images 16 include: Analyze from AnalyzeDirect, Inc.,Overland Park, Kans.; Insight Toolkit, an open-source software availablefrom the National Library of Medicine Insight Segmentation andRegistration Toolkit (“ITK”), www.itk.org; 3D Slicer, an open-sourcesoftware available from www.slicer.org; Mimics from Materialise, AnnArbor, Mich.; and Paraview available at www.paraview.org.

As indicated in FIG. 1C, the 3D computer generated bone models 22 areutilized to create 3D computer generated “restored bone models” or“planning bone models” 28 wherein the degenerated surfaces 24, 26 aremodified or restored to approximately their respective conditions priorto degeneration [block 115]. Thus, the bones 18, 20 of the restored bonemodels 28 are reflected in approximately their condition prior todegeneration. The restored bone models 28 are located such that point Pis at coordinates (X_(0-j), Y_(0-j), Z_(0-j)) relative to the origin(X₀, Y₀, Z₀). Thus, the restored bone models 28 share the sameorientation and positioning relative to the origin (X₀, Y₀, Z₀) as thebone models 22.

In one embodiment, the restored bone models 28 are manually created fromthe bone models 22 by a person sitting in front of a computer 6 andvisually observing the bone models 22 and their degenerated surfaces 24,26 as 3D computer models on a computer screen 9. The person visuallyobserves the degenerated surfaces 24, 26 to determine how and to whatextent the degenerated surfaces 24, 26 surfaces on the 3D computer bonemodels 22 need to be modified to restore them to their pre-degeneratedcondition. By interacting with the computer controls 11, the person thenmanually manipulates the 3D degenerated surfaces 24, 26 via the 3Dmodeling computer program to restore the surfaces 24, 26 to a state theperson believes to represent the pre-degenerated condition. The resultof this manual restoration process is the computer generated 3D restoredbone models 28, wherein the surfaces 24′, 26′ are indicated in anon-degenerated state.

In one embodiment, the above-described bone restoration process isgenerally or completely automated, as disclosed in U.S. patentapplication Ser. No. 12/111,924 to Park, which is entitled Generation ofa Computerized Bone Model Representative of a Pre-Degenerated State andUsable in the Design and Manufacture of Arthroplasty Devices, was filedApr. 29, 2008 and is incorporated by reference in its entirety into thisDetailed Description. In other words, a computer program may analyze thebone models 22 and their degenerated surfaces 24, 26 to determine howand to what extent the degenerated surfaces 24, 26 surfaces on the 3Dcomputer bone models 22 need to be modified to restore them to theirpre-degenerated condition. The computer program then manipulates the 3Ddegenerated surfaces 24, 26 to restore the surfaces 24, 26 to a stateintended to represent the pre-degenerated condition. The result of thisautomated restoration process is the computer generated 3D restored bonemodels 28, wherein the surfaces 24′, 26′ are indicated in anon-degenerated state.

As depicted in FIG. 1C, the restored bone models 28 are employed in apre-operative planning (“POP”) procedure to determine saw cut locations30 and drill hole locations 32 in the patient's bones that will allowthe arthroplasty joint implants to generally restore the patient's jointline to its pre-degenerative alignment [block 120].

In one embodiment, the POP procedure is a manual process, whereincomputer generated 3D implant models 34 (e.g., femur and tibia implantsin the context of the joint being a knee) and restored bone models 28are manually manipulated relative to each other by a person sitting infront of a computer 6 and visually observing the implant models 34 andrestored bone models 28 on the computer screen 9 and manipulating themodels 28, 34 via the computer controls 11. By superimposing the implantmodels 34 over the restored bone models 28, or vice versa, the jointsurfaces of the implant models 34 can be aligned or caused to correspondwith the joint surfaces of the restored bone models 28. By causing thejoint surfaces of the models 28, 34 to so align, the implant models 34are positioned relative to the restored bone models 28 such that the sawcut locations 30 and drill hole locations 32 can be determined relativeto the restored bone models 28.

In one embodiment, the POP process is generally or completely automated.For example, a computer program may manipulate computer generated 3Dimplant models 34 (e.g., femur and tibia implants in the context of thejoint being a knee) and restored bone models or planning bone models 28relative to each other to determine the saw cut and drill hole locations30, 32 relative to the restored bone models 28. The implant models 34may be superimposed over the restored bone models 28, or vice versa. Inone embodiment, the implant models 34 are located at point P′ (X_(0-k),Y_(0-k), Z_(0-k)) relative to the origin (X₀, Y₀, Z₀), and the restoredbone models 28 are located at point P (X_(0-j), Y_(0-j), Z_(0-j)). Tocause the joint surfaces of the models 28, 34 to correspond, thecomputer program may move the restored bone models 28 from point P(X_(0-j), Y_(0-j), Z_(0-j)) to point P′ (X_(0-k), Y_(0-k), Z_(0-k)), orvice versa. Once the joint surfaces of the models 28, 34 are in closeproximity, the joint surfaces of the implant models 34 may beshape-matched to align or correspond with the joint surfaces of therestored bone models 28. By causing the joint surfaces of the models 28,34 to so align, the implant models 34 are positioned relative to therestored bone models 28 such that the saw cut locations 30 and drillhole locations 32 can be determined relative to the restored bone models28. A discussion of various embodiments of the automated POP process isprovided later in this Detailed Description.

As indicated in FIG. 1E, in one embodiment, the data 44 regarding thesaw cut and drill hole locations 30, 32 relative to point P′ (X_(0-k),Y_(0-k), Z_(0-k)) is packaged or consolidated as the “saw cut and drillhole data” 44 [block 145]. The “saw cut and drill hole data” 44 is thenused as discussed below with respect to [block 150] in FIG. 1E.

As can be understood from FIG. 1D, the 2D images 16 employed to generatethe bone models 22 discussed above with respect to [block 110] of FIG.1C are also used to create computer generated 3D bone and cartilagemodels (i.e., “arthritic models”) 36 of the bones 18, 20 forming thepatient's joint 14 [block 130]. Like the above-discussed bone models 22,the arthritic models 36 are located such that point P is at coordinates(X_(0-j), Y_(0-j), Z_(0-j)) relative to the origin (X₀, Y₀, Z₀) of theX-Y-Z axis [block 130]. Thus, the bone and arthritic models 22, 36 sharethe same location and orientation relative to the origin (X₀, Y₀, Z₀).This position/orientation relationship is generally maintainedthroughout the process discussed with respect to FIGS. 1B-1E.Accordingly, movements relative to the origin (X₀, Y₀, Z₀) of the bonemodels 22 and the various descendants thereof (i.e., the restored bonemodels 28, bone cut locations 30 and drill hole locations 32) are alsoapplied to the arthritic models 36 and the various descendants thereof(i.e., the jig models 38). Maintaining the position/orientationrelationship between the bone models 22 and arthritic models 36 andtheir respective descendants allows the “saw cut and drill hole data” 44to be integrated into the “jig data” 46 to form the “integrated jigdata” 48 employed by the CNC machine 10 to manufacture the customizedarthroplasty jigs 2.

Computer programs for creating the 3D computer generated arthriticmodels 36 from the 2D images 16 include: Analyze from AnalyzeDirect,Inc., Overland Park, Kans.; Insight Toolkit, an open-source softwareavailable from the National Library of Medicine Insight Segmentation andRegistration Toolkit (“ITK”), www.itk.org; 3D Slicer, an open-sourcesoftware available from www.slicer.org; Mimics from Materialise, AnnArbor, Mich.; and Paraview available at www.paraview.org.

Similar to the bone models 22, the arthritic models 36 depict the bones18, in the present deteriorated condition with their respectivedegenerated joint surfaces 24, 26, which may be a result ofosteoarthritis, injury, a combination thereof, etc. However, unlike thebone models 22, the arthritic models 36 are not bone-only models, butinclude cartilage in addition to bone. Accordingly, the arthritic models36 depict the arthroplasty target areas 42 generally as they will existwhen the customized arthroplasty jigs 2 matingly receive thearthroplasty target areas 42 during the arthroplasty surgical procedure.

As indicated in FIG. 1D and already mentioned above, to coordinate thepositions/orientations of the bone and arthritic models 22, 36 and theirrespective descendants, any movement of the restored bone models 28 frompoint P to point P′ is tracked to cause a generally identicaldisplacement for the “arthritic models” 36 [block 135].

As depicted in FIG. 1D, computer generated 3D surface models 40 of thearthroplasty target areas 42 of the arthritic models 36 are importedinto computer generated 3D arthroplasty jig models 38 [block 140]. Thus,the jig models 38 are configured or indexed to matingly receive thearthroplasty target areas 42 of the arthritic models 36. Jigs 2manufactured to match such jig models 38 will then matingly receive thearthroplasty target areas of the actual joint bones during thearthroplasty surgical procedure.

In one embodiment, the procedure for indexing the jig models 38 to thearthroplasty target areas 42 is a manual process. The 3D computergenerated models 36, 38 are manually manipulated relative to each otherby a person sitting in front of a computer 6 and visually observing thejig models 38 and arthritic models 36 on the computer screen 9 andmanipulating the models 36, 38 by interacting with the computer controls11. In one embodiment, by superimposing the jig models 38 (e.g., femurand tibia arthroplasty jigs in the context of the joint being a knee)over the arthroplasty target areas 42 of the arthritic models 36, orvice versa, the surface models 40 of the arthroplasty target areas 42can be imported into the jig models 38, resulting in jig models 38indexed to matingly receive the arthroplasty target areas 42 of thearthritic models 36. Point P′ (X_(0-k), Y_(0-k), Z_(0-k)) can also beimported into the jig models 38, resulting in jig models 38 positionedand oriented relative to point P′ (X_(0-k), Y_(0-k), Z_(0-k)) to allowtheir integration with the bone cut and drill hole data 44 of [block125].

In one embodiment, the procedure for indexing the jig models 38 to thearthroplasty target areas 42 is generally or completely automated, asdisclosed in U.S. patent application Ser. No. 11/959,344 to Park, whichis entitled System and Method for Manufacturing Arthroplasty Jigs, wasfiled Dec. 18, 2007 and is incorporated by reference in its entiretyinto this Detailed Description. For example, a computer program maycreate 3D computer generated surface models 40 of the arthroplastytarget areas 42 of the arthritic models 36. The computer program maythen import the surface models 40 and point P′ (X_(0-k), Y_(0-k),Z_(0-k)) into the jig models 38, resulting in the jig models 38 beingindexed to matingly receive the arthroplasty target areas 42 of thearthritic models 36. The resulting jig models 38 are also positioned andoriented relative to point P′ (X_(0-k), Y_(0-k), Z_(0-k)) to allow theirintegration with the bone cut and drill hole data 44 of [block 125].

In one embodiment, the arthritic models 36 may be 3D volumetric modelsas generated from the closed-loop process discussed in U.S. patentapplication Ser. No. 11/959,344 filed by Park. In other embodiments, thearthritic models 36 may be 3D surface models as generated from theopen-loop process discussed in U.S. patent application Ser. No.11/959,344 filed by Park.

In one embodiment, the models 40 of the arthroplasty target areas 42 ofthe arthritic models 36 may be generated via an overestimation processas disclosed in U.S. Provisional Patent Application 61/083,053, which isentitled System and Method for Manufacturing Arthroplasty Jigs HavingImproved Mating Accuracy, was filed by Park Jul. 23, 2008, and is herebyincorporated by reference in its entirety into this DetailedDescription.

As indicated in FIG. 1E, in one embodiment, the data regarding the jigmodels 38 and surface models 40 relative to point P′ (X_(0-k), Y_(0-k),Z_(0-k)) is packaged or consolidated as the “jig data” 46 [block 145].The “jig data” 46 is then used as discussed below with respect to [block150] in FIG. 1E.

As can be understood from FIG. 1E, the “saw cut and drill hole data” 44is integrated with the “jig data” 46 to result in the “integrated jigdata” 48 [block 150]. As explained above, since the “saw cut and drillhole data” 44, “jig data” 46 and their various ancestors (e.g., models22, 28, 36, 38) are matched to each other for position and orientationrelative to point P and P′, the “saw cut and drill hole data” 44 isproperly positioned and oriented relative to the “jig data” 46 forproper integration into the “jig data” 46. The resulting “integrated jigdata” 48, when provided to the CNC machine 10, results in jigs 2: (1)configured to matingly receive the arthroplasty target areas of thepatient's bones; and (2) having cut slots and drill holes thatfacilitate preparing the arthroplasty target areas in a manner thatallows the arthroplasty joint implants to generally restore thepatient's joint line to its pre-degenerated state or natural alignmentstate.

As can be understood from FIGS. 1A and 1E, the “integrated jig data” 48is transferred from the computer 6 to the CNC machine 10 [block 155].Jig blanks 50 are provided to the CNC machine 10 [block 160], and theCNC machine 10 employs the “integrated jig data” to machine thearthroplasty jigs 2 from the jig blanks 50.

For a discussion of example customized arthroplasty cutting jigs 2capable of being manufactured via the above-discussed process, referenceis made to FIGS. 1F-1I. While, as pointed out above, the above-discussedprocess may be employed to manufacture jigs 2 configured forarthroplasty procedures involving knees, elbows, ankles, wrists, hips,shoulders, vertebra interfaces, etc., the jig examples depicted in FIGS.1F-1I are for total knee replacement (“TKR”) or partial knee(“uni-knee”) replacement procedures. Thus, FIGS. 1F and 1G are,respectively, bottom and top perspective views of an example customizedarthroplasty femur jig 2A, and FIGS. 1H and 1I are, respectively, bottomand top perspective views of an example customized arthroplasty tibiajig 2B.

As indicated in FIGS. 1F and 1G, a femur arthroplasty jig 2A may includean interior side or portion 100 and an exterior side or portion 102.When the femur cutting jig 2A is used in a TKR procedure, the interiorside or portion 100 faces and matingly receives the arthroplasty targetarea 42 of the femur lower end, and the exterior side or portion 102 ison the opposite side of the femur cutting jig 2A from the interiorportion 100.

The interior portion 100 of the femur jig 2A is configured to match thesurface features of the damaged lower end (i.e., the arthroplasty targetarea 42) of the patient's femur 18. Thus, when the target area 42 isreceived in the interior portion 100 of the femur jig 2A during the TKRsurgery, the surfaces of the target area 42 and the interior portion 100match.

The surface of the interior portion 100 of the femur cutting jig 2A ismachined or otherwise formed into a selected femur jig blank 50A and isbased or defined off of a 3D surface model 40 of a target area 42 of thedamaged lower end or target area 42 of the patient's femur 18.

As indicated in FIGS. 1H and 1I, a tibia arthroplasty jig 2B may includean interior side or portion 104 and an exterior side or portion 106.When the tibia cutting jig 2B is used in a TKR procedure, the interiorside or portion 104 faces and matingly receives the arthroplasty targetarea 42 of the tibia upper end, and the exterior side or portion 106 ison the opposite side of the tibia cutting jig 2B from the interiorportion 104.

The interior portion 104 of the tibia jig 2B is configured to match thesurface features of the damaged upper end (i.e., the arthroplasty targetarea 42) of the patient's tibia 20. Thus, when the target area 42 isreceived in the interior portion 104 of the tibia jig 2B during the TKRsurgery, the surfaces of the target area 42 and the interior portion 104match.

The surface of the interior portion 104 of the tibia cutting jig 2B ismachined or otherwise formed into a selected tibia jig blank 50B and isbased or defined off of a 3D surface model 40 of a target area 42 of thedamaged upper end or target area 42 of the patient's tibia 20.

While the discussion provided herein is given in the context of TKR andTKR jigs and the generation thereof. However, the disclosure providedherein is readily applicable to uni-compartmental or partialarthroplasty procedures in the knee or other joint contexts. Thus, thedisclosure provided herein should be considered as encompassing jigs andthe generation thereof for both total and uni-compartmental arthroplastyprocedures.

The remainder of this Detailed Discussion will now focus on variousembodiments for performing POP.

B. Overview of Preoperative Planning (“POP”) Procedure

In one embodiment, as can be understood from [blocks 100-120] of FIGS.1B-1C and from FIGS. 1J and 1K, which contain portions of a flow chartillustrating an overview of the POP system and method disclosed herein,medical images 16 of the femur and tibia 18, 20 are generated and formedinto three dimensional (“3D”) bone models 22, which are then restored ormodified into restored bone models 28′, 28″ to represent the patient'sfemur and tibia 18, 20 prior to injury or degeneration [block 171].Three dimensional computer models 34′, 34″ of the femur and tibiaimplants are generated from engineering drawings of the implants and maybe generated via any of the above-referenced 3D modeling programs [block172]. The sizes of the implant models 34′, 34″ are selected relative tothe femur and tibia restored bone models 28′, 28″ [block 173]. The femurand tibia restored bone models 28′, 28″ are moved towards the implantmodels 34′, 34″ to superimpose the femur and tibia restored bone models28′, 28″ over the implant models 34′, 34″ [block 174]. Landmarkreference lines for the femur restored bone model 28′ are determined[block 175]. The elliptical contours of the femoral condyles 430, 445are determined from the landmark reference lines [block 125]. Theelliptical contours 505, 510 for the lateral and medial condyles 515,520 of the femur implant model 34′ are determined [block 176]. Thelateral and medial condyles 515, 520 of the femur implant model 34′ arealigned with the lateral and medial condyles 430, 445 of the femurrestored bone model 28′ [block 177]. The superposing of the femurrestored bone model 28′ with the implant model 34′ is refined byaligning the condyles of the of the femur restored bone model 28′ withthe condyles of the implant model 34′ [block 178]. An asymmetrical orsymmetrical femoral implant model 34′ is selected for the shape matchingprocess [block 179]. An adjustment value tr is determined to account forcartilage thickness or joint gap of a restored joint [block 180]. Theimplant model 34′ is modified according to the adjustment value tr[block 181]. The shape matching process takes place where the articularcondylar surfaces of the modified implant model 34′ are shape matched tothe articular condylar surfaces of the restored bone model 28′. Theprocess then continues as indicated in [block 125] of FIG. 1E.

As indicated in FIG. 1J with respect to the tibia, areas of interest areidentified for the tibia restored model [block 183]. Reference pointsare identified for the tibia restored bone model and the tibia implantmodel [block 184]. An adjustment value tr is determined for the tibiaimplant model [block 185]. Slope vectors are identified for the tibiarestored bone model [block 186] and the tibia implant model [block 187].Potential IR/ER misalignment is addressed [block 188]. The tibia implantmodel is modified according to the adjustment value tr [block 189]. Thecondylar articular surfaces of tibia implant model are shape matched tothose of the tibia restored bone model [block 190].

This ends the overview of the POP process. The following discussionswill address each of the aspects of the POP process in detail.

C. Computer Modeling Femur and Tibia

FIG. 2A depicts 3D computer generated restored bone models 28′, 28″ ofthe femur and tibia 18, 20 generated from medical imaging scans 16 andrepresenting the patient's femur 18 and tibia 20 prior to injury ordegeneration [see block 171 of FIG. 1J]. More specifically, FIG. 2A isan isometric view of a 3D computer model 28′ of a femur lower end 200and a 3D computer model 28″ of a tibia upper end 205 representative ofthe corresponding patient bones 18, 20 in a non-deteriorated state andin position relative to each to form a knee joint 14. The femur lowerend 200 includes condyles 215, and the tibia upper end 205 includes aplateau 220. The models 28′, 28″ are positioned relative to each othersuch that the curved articular surfaces of the condyles 215, which wouldnormally mate with complementary articular surfaces of the plateau 220,are instead not mating, but roughly positioned relative to each other togenerally for the knee joint 14.

As generally discussed above with respect to FIGS. 1A-1C, the POP beginsby using a medical imaging process, such as magnetic resonance imaging(MRI), computed tomography (CT), and/or another other medical imagingprocess, to generate imaging data of the patient's knee. The generatedimaging data is sent to a preoperative planning computer program. Uponreceipt of the data, the computer program converts the data (e.g.,two-dimensional MRI images 16) into 3D anatomical computer bone models22 of the knee joint 14 with the aid of a medical imaging conversioncomputer program, the bone models 22 being representative of thepatient's bones 18, 20 in the current deteriorated state. For example,current commercially available MRI machines use 8 bit (255 grayscale) toshow the human anatomy. Therefore, certain components of the knee, suchas the cartilage, cortical bone, cancellous bone, meniscus, etc., can beuniquely viewed and recognized with 255 grayscale.

As provided in U.S. patent application Ser. No. 12/111,924 to Park,which is entitled Generation of a Computerized Bone Model Representativeof a Pre-Degenerated State and Usable in the Design and Manufacture ofArthroplasty Devices, was filed Apr. 29, 2008 and is incorporated byreference in its entirety into this Detailed Description, specializedmedical converging software recognizes the anatomy of the knee andshapes the bone models 22 using mathematical algorithms, such assequences of n^(th) order polynomials, where n is greater than or equalto 3. A technique such as surface-rendering is then used to construct 3Drestored bone models 28′, 28″ of the knee joint 14 from the bone models22. Examples of medical imaging computer programs that may be used hereinclude Analyze (from AnalyzeDirect, Inc., Overland Park, Kans.),open-source software such as the Insight Toolkit (ITK, www.itk.org) and3D Slicer (www.slicer.org), and Mimics (from Materialise, Ann Arbor,Mich.).

In one embodiment, the resulting 3D restored bone models 28′, 28″ of thefemur portion 200 and tibia portion 205 forming the knee joint 14include the cortical bone of the femur 18 and the tibia 20. Depending onthe embodiment, the restored bone models 28′, 28″ may includes articularcartilage attached to the distal region of the femur 18 and the proximalregion of the tibia 20. The computer program may automatically excludethe rest of the soft tissue, as well as the cancellous bone, from the 3Dcomputer models 28′, 28″, although in some variations the computerprogram may not automatically exclude the rest of the soft tissue and/orthe cancellous bone.

The 3D computer generated femur and tibia restored bone models 28′, 28″are repaired versions of the patient's femur 18 and tibia 20 as thesebones are believed to have existed before degenerating into theircurrent existing date, the current state of the patient's femur 18 andtibia 20 being represented by the 3D bone models 22. In other words, thefemur and tibia computer generated bone models 22 resulting from the MRIscans depict the femur 18 and tibia 20 in the current deterioratedstate. These models 22 are then modified or restored into restored bonemodels 28′, 28″ to represent the femur 18 and tibia 20 as they likelyappeared before beginning to degenerate. The resulting modified orrestored models 28′, 28″ can then be used for planning purposes, asdescribed later in this Detailed Description.

For greater detail regarding the methods and systems for computermodeling joint bones, such as the femur and tibia bones forming theknee, please see the following U.S. patent applications, which are allincorporated herein in their entireties: U.S. patent application Ser.No. 11/656,323 to Park et al., titled “Arthroplasty Devices and RelatedMethods” and filed Jan. 19, 2007; U.S. patent application Ser. No.10/146,862 to Park et al., titled “Improved Total Joint ArthroplastySystem” and filed May 15, 2002; U.S. patent Ser. No. 11/642,385 to Parket al., titled “Arthroplasty Devices and Related Methods” and filed Dec.19, 2006; and U.S. patent application Ser. No. 12/111,924 to Park,titled “Generation of a Computerized Bone Model Representative of aPre-Degenerated State and Usable in the Design and Manufacture ofArthroplasty Devices” and filed Apr. 29, 2008.

FIG. 2B is an isometric view of a computer model of a femur implant 34′and a computer model of a tibia implant 34″ in position relative to eachto form an artificial knee joint 14. The computer models 34′, 34″ may beformed, for example, via computer aided drafting or 3D modeling programs[see block 172 of FIG. 1J].

The femur implant model 34′ will have a joint side 240 and a boneengaging side 245. The joint side 240 will have a condoyle-like surfacefor engaging a complementary surface of the tibia implant model 34″. Thebone engaging side 245 will have surfaces and engagement features 250for engaging the prepared (i.e., sawed to shape) lower end of the femur18.

The tibia implant model 34″ will have a joint side 255 and a boneengaging side 260. The joint side 255 will have a plateau-like surfaceconfigured to engage the condoyle-like surface of the femur implantmodel 34′. The bone engaging side 260 will have an engagement feature265 for engaging the prepared (i.e., sawed to shape) upper end of thetibia 20.

As discussed in the next subsection of this Detailed Description, thefemur and tibia restored bone models 28′, 28″ may be used in conjunctionwith the implant models 34′, 34″ to select the appropriate sizing forthe implants actually to be used for the patient.

D. Selecting the Sizes for the Femoral and Tibial Implants

FIG. 3A is a plan view of the joint side 240 of the femur implant model34′ depicted in FIG. 2B. FIG. 3B is an axial end view of the femur lowerend 200 of the femur restored bone model 28′ depicted in FIG. 2A andshowing the condoyle surfaces 215. The views depicted in FIGS. 3A and 3Bare used to select the proper size for the femoral implant model 34′[see block 173 of FIG. 1J].

As can be understood from FIG. 3A, each femoral implant available viathe various implant manufactures may be represented by a specificfemoral implant 3D computer model 34′ having a size and dimensionsspecific to the actual femoral implant. Thus, the representative implantmodel 34′ of FIG. 3A may have an associated size and associateddimensions in the form of, for example, an anterior-posterior extent iAPand medial-lateral extent iML. These implant extents iAP, iML may becompared to the dimensions of the femur restored bone model 28′ thatrepresents the patient's femur 18 as it may have existed prior todegeneration or injury. For example, the femur restored bone model 28′may have dimensions such as, for example, an anterior-posterior extentbAP and a medial-lateral extent bML, as shown in FIG. 3B. In FIG. 3A,the anterior-posterior extent iAP of the femoral implant model 34′ ismeasured from the anterior edge 270 to the posterior edge 275 of thefemoral implant model 34′, and the medial-lateral extent iML is measuredfrom the medial edge 280 to the lateral edge 285 of the femoral implantmodel 34′.

Each patient has femurs that are unique in size and configuration fromthe femurs of other patients. Accordingly, each femur restored bonemodel 28′ will be unique in size and configuration to match the size andconfiguration of the femur medically imaged. As can be understood fromFIG. 3B, the femoral anterior-posterior length bAP is measured from theanterior edge 290 of the patellofemoral groove to the posterior edge 295of the femoral condyle, and the femoral medial-lateral length bML ismeasured from the medial edge 300 of the medial condyle to the lateraledge 305 of the lateral condyle.

As can be understood from FIG. 3C, which is a flow chart depicting theprocess undertaken by the system 4 when selecting the femur implantmodel 34′ corresponding to the appropriate femur implant size to be usedin the actual arthroplasty procedure, the system 4 determines thefemoral anterior-posterior length bAP and the femoral medial-laterallength bML for, the femur restored bone model 28′ [block 1000].

In one embodiment, there is a limited number of sizes of a candidatefemoral implant. For example, one manufacturer may supply six sizes offemoral implants and another manufacturer may supply eight or anothernumber of femoral implants. The iAP and iML dimensions of thesecandidate implants may be stored in a database. The bAP and bML arecompared to the iAP and iML of candidate femoral implants stored in thedatabase [block 1005]. The system 4 selects a femoral implant model 34′corresponding to a candidate femoral implant having iAP and iML thatsatisfies the following two relationships: bML≧iML+ε, wherein −2 mm<ε<5mm; and bAP≧iAP+σ, where −4 mm<σ<4 mm [block 1010]. As an alternative to[block 1010], in one embodiment, instead of selecting from a limitednumber of candidate femoral implants, these two relationships are usedto manufacture a custom sized femoral implant.

Still referring to FIG. 3C and continuing from [block 1010], the system4 provides the computer modeled femoral implant 34′ corresponding to theselected candidate femoral implant [block 1015]. This computer modeledfemoral implant 34′, which corresponds to the selected candidate femoralimplant, is used with the computer modeled femur restored bone model 28′in computer modeling a femoral arthroplasty jig, as discussed later inthis Detailed Description.

FIG. 3D is a plan view of the joint side 255 of the tibia implant model34″ depicted in FIG. 2B. FIG. 3E is an axial end view of the tibia upperend 205 of the tibia restored bone model 28″ of FIG. 2A and showing theplateau 220. The views depicted in FIGS. 3D and 3E are used to selectthe proper size for the tibial implant model 34″.

As can be understood from FIG. 3D, each tibial implant available via thevarious implant manufactures may be represented by a specific tibiaimplant 3D computer model 34″ having a size and dimensions specific tothe actual tibia implant. Thus, the representative implant model 34″ ofFIG. 3D may have an associated size and associated dimensions in theform of, for example, anterior-posterior extent cAP and themedial-lateral extent cML of the tibia model 34″, as shown in FIG. 3E.In FIG. 3D, the anterior-posterior extent jAP of the tibia implant model34″ is measured from the anterior edge 310 to the posterior edge 315 ofthe tibial implant model 34″, and the medial-lateral extent jML ismeasured from the medial edge 320 to the lateral edge 325 of the tibialimplant model 34″.

Each patient has tibias that are unique in size and configuration fromthe tibias of other patients. Accordingly, each tibia restored bonemodel 28″ will be unique in size and configuration to match the size andconfiguration of the tibia medically imaged. As can be understood fromFIG. 3E, the tibial anterior-posterior length cAP is measured from theanterior edge 330 of the of the tibial restored bone model 28″ to theposterior edge 335 of the tibial restored bone model 28″, and the tibialmedial-lateral length cML is measured from the medial edge 340 of themedial plateau of the tibia restored bone model 28″ to the lateral edge345 of the lateral plateau of the tibia restored bone model 28″.

As can be understood from FIG. 3F, which is a flow chart depicting theprocess undertaken by the system 4 when selecting the tibia implantmodel 34″ corresponding to the appropriate tibia implant size to be usedin the actual arthroplasty procedure, the system 4 determines the tibialanterior-posterior length cAP and the tibial medial-lateral length cML[block 1020].

In one embodiment, there is a limited number of sizes of a candidatetibia implant. For example, one manufacturer may supply six sizes oftibia implants and another manufacturer may supply eight or anothernumber of tibia implants. The jAP and jML dimensions of these candidateimplants may be stored in a database. The cAP and cML are compared tothe jAP and jML of candidate tibia implants stored in the database[block 1025]. The system 4 selects a tibia implant model 34″corresponding to a candidate tibia implant having jAP and jML thatsatisfies the following two relationships: cML≧jML+ω, wherein −2 mm<ω<4mm; and cAP≧jAP+θ, where −2 mm<θ<4 mm [block 1030]. As an alternative to[block 1030], in one embodiment, instead of selecting from a limitednumber of candidate tibia implants, these two relationships are used tomanufacture a custom sized tibia implant.

Still referring to FIG. 3F and continuing from [block 1030], the system4 provides the computer modeled tibia implant 34″ corresponding to theselected candidate tibia implant [block 1035]. This computer modeledtibia implant 34″, which corresponds to the selected candidate tibiaimplant, is used with the computer modeled tibia restored bone model 28″in computer modeling a tibia arthroplasty jig, as discussed later inthis Detailed Description.

Femoral and tibial implants represented by the implant models 34′, 34″,such as those depicted in FIG. 2B, are commercially available. Examplesof commercially available implants include the Vanguard™ prostheticfemoral arthroplasty implants (manufactured by Biomet, Inc.), theTriathlon® Knee System (from Stryker® Orthopedics), and the P.F.C.®Sigma Knee System (from Depuy).

E. Moving Femur and Tibia Models Towards Corresponding Implant ModelsSuch That Femur and Tibia Models are Superimposed Over the ImplantModels.

As explained above with respect to [blocks 100-115] of FIGS. 1A-1C, therestored bone models 28′, 28″ can be reconstructed from bone models 22generated from the plurality of MRI image slices 16, which are scannedaround a live patient's knee 14. As can be understood from [blocks100-115] of FIGS. 1A-1C, the image slices 16, bone models 22 andrestored bone models 28 may be positioned at a coordinate point P(X_(0-j), Y_(0-j), Z_(0-j)) relative to an origin X₀, Y₀, Z₀ of an X-Y-Zaxis throughout their respective generations and existences. Similarly,the implant models 34 may be positioned at a coordinate point P(X_(0-k), Y_(0-k), Z_(0-k)) relative to the origin X₀, Y₀, Z₀ of theX-Y-Z axis throughout their existence. Thus, as indicated in FIG. 4A,which is an isometric view of the restored bone models 28 and implantmodels 34, the restored bone models 28 may be positioned such that apoint P_(RBM) associated with the restored bone models 28 occupiescoordinate point P (X_(0-j), Y_(0-j), Z_(0-j)) relative the origin X₀,Y₀, Z₀ of the X-Y-Z axis, and the implant models 34 may be positionedsuch that a point P_(IM) associated with the implant models 34 occupiescoordinate point P (X_(0-k), Y_(0-k), Z_(0-k)) relative the origin X₀,Y₀, Z₀ of the X-Y-Z axis.

As indicated by arrows A in FIG. 4A, the restored bone models 28 andimplant models 34 may be moved together to superimpose one type of modelover the other type of model. For example, in one embodiment, theimplant models 34 are held stationary at coordinate point P (X_(0-k),Y_(0-k), Z_(0-k)) and, as indicated by arrows A, the restored bonemodels 28 are moved from coordinate point P (X_(0-j), Y_(0-j), Z_(0-j))to coordinate point (X_(0-k), Y_(0-k), Z_(0-k)) such that point P_(RBM)of the restored bone models 28 moves from coordinate point P (X_(0-j),Y_(0-j), Z_(0-j)) to coordinate point (X_(0-k), Y_(0-k), Z_(0-k)). As aresult and as indicated in FIG. 4B, which is an isometric view of therestored bone models 28 superimposed over the implant models 34, pointsP_(RBM) and P_(IM) end up both being generally occupying coordinatepoint (X_(0-k), Y_(0-k), Z_(0-k)) such that the models 28, 34 aresuperimposed.

As mentioned above with respect to the discussion of [block 135] of FIG.1D, movement of the restored bone models 28 during the POP or otherprocess from coordinate point P (X_(0-j), Y_(0-j), Z_(0-j)) to anothercoordinate point, such as, coordinate point (X_(0-k), Y_(0-k), Z_(0-k)),is reflected or mimicked by the arthritic models 36 such that thelocation and orientation of the arthritic models 36 matches those of therestored bone models 28, thereby facilitating the combining of the datatypes 44, 46 into the integrated jig data 48, as discussed in [block150] of FIG. 1E.

In one embodiment, the point P_(IM) associated with the implant models34 is located between the implant models 34′, 34″ close to theircenters, near the intercondylar notch of the femur implant model 34′,and the point P_(RBM) associated with the restored bone models 28 islocated between the restored bone models 28′, 28″ close to theircenters, near the intercondylar notch of the femur restored bone model28′. Of course, depending on the embodiment, the points P_(IM), P_(RBM)may be located at other locations relative to their respective models34, 28 as long as the locations of the points P_(IM), P_(RBM) relativeto their respective models 34, 28 are generally coordinated with eachother. For example, points P_(IM), P_(RBM) could be positioned relativeto their respective models 34, 28 such that the points P_(IM), P_(RBM)are generally centered at the most distal point of the medial articularcondylar surface of each respective model 34, 28.

The preceding example is given in the context of holding the implantmodels 34 in place and moving the restored bone models 28 to the implantmodels 34 to superimpose the restored bone models 28 over the implantmodels 34. However, in other embodiments, the reverse situation may bethe case, wherein the restored bone models 28 are held in place and theimplant models 34 are moved to the restored bone models 28 tosuperimpose the implant models 34 over the restored bone models 28.

In summary, as can be understood from FIGS. 4A-4B and FIG. 4C, which isa flow chart summarizing the process of superimposing the models 28, 34over each other as mention in [block 174] of FIG. 1J, the implantreference point P_(IM) is designated as coordinate point (X_(0-k),Y_(0-k), Z_(0-k)) with respect to an X-Y-Z coordinate system having anorigin at coordinate point (X₀, Y₀, Z₀) [block 1035]. The implantreference point P_(IM) may be located between the implants models 34′,34″, close to their centers, near the intercondylar notch of the femurimplant model 34′. The restored bone model reference point P_(RBM) isdesignated as coordinate point (X_(0-j), Y_(0-j), Z_(0-j)) with respectto the X-Y-Z coordinate system having its origin at coordinate point(X₀, Y₀, Z₀) [block 1040]. The restored bone model reference pointP_(RBM) may be located between the restored bone models 28′, 28″, closeto their centers, near the intercondylar notch of the femur restoredbone model 28′.

In one embodiment, in the image analysis of the POP, the restored bonemodels 28′, 28″ may be translated to near the corresponding implantsmodels 34′, 34″ through a distance (α, β, γ) by f (x−α, y−β, z−γ), whereα=X_(0-k)−X_(0-j); β=Y_(0-k)−Y_(0-j); and γ=Z_(0-k)−Z_(0-j) [block1045]. In other words, the restored bone models 28′, 28″ are moved tothe implant models 34′, 34″ such that the two reference points P_(RBM),P_(IM) are generally in the same location. Therefore, the restored bonemodels 28′, 28″ and the implants models 34′, 34″ are closelysuperimposed to provide the starting reference points for translationaland, rotational positioning of the femoral and tibial implants models34′, 34″ with respect to the femur and tibia restored bone models 28′,28″ for the shape matching process discussed in the followingsubsections of this Detailed Discussion. In other words, theabove-described superimposing of the models 28, 34 may act as an initialrough positioning of the models in preparation for the following shapematching process.

F. Refining Positioning Between Bone and Implant Models

Once the bone and implant models 28, 34 are roughly positioned relativeto each other via the above-described superimposing process, thepositioning of the bone and implant models 28, 34 relative to each otheris further refined prior to the shape matching process. The positionrefining process first entails the identification of landmark referenceplanes for the femur model, the utilization of the landmark referenceplanes to identify the elliptical contours of the femur restored bonemodel, and then the correlation of the femur elliptical contours tocorresponding elliptical contours of the implant model in an approximatemanner.

1. Determining Landmark Reference Planes for Femur Model.

The determination of the landmark reference planes for the femur modelmay be made via at least two methods. For example, a first methodentails employing asymptotic lines to identify the landmark referenceplanes. In a second method, the landmark reference planes are identifiedvia their relationship to a trochlear groove plane.

i. Landmark Reference Planes Identified Via Asymptotic Lines

FIGS. 5A-5C illustrate a process in the POP wherein the system 4determines landmark reference planes via asymptotic lines for the femurrestored bone model 28′ (see FIG. 1J [block 175]) relative to acoordinate system axis 410. FIG. 5C is a flow chart illustrating theprocess for determining the landmark references. FIG. 5A is a view ofthe lateral side of the lower or distal portion of the femur restoredbone model 28′ illustrating how to determine landmark reference planesfor the posterior and anterior sides 415, 420 of the femur planningmodel, which is also known as the femur restored bone model 28′. Asindicated in FIGS. 5A and 5C, an asymptotic line-cd can be obtained bythe exponential function, y=α+β EXP (−μ(x−ω)), from the anterior-distalfemur along the anterior side 420 of the femoral shaft 423 [block 1050].To obtain the tangent contact spot 425 representing the posteriorextremity of lateral femoral condyle 430, the line-ab along thecurvature of femoral condyle can be identified by using the asymptoticline-cd, where lines-cd, ab are parallel to each other, or where line-abis substantially parallel to line-cd such that the acute angle betweenlines-cd, ab is less than approximately five degrees [block 1055]. Insome embodiments, line-ab may represent a plane-ab that includes line-aband is generally perpendicular to the sagittal image slice planes 16used to form the restored bone model, as discussed with respect to FIGS.1B-1C.

FIG. 5B is an anterior or coronal view of FIG. 5A illustrating how todetermine landmark reference planes for the medial and lateral sides435, 440 of the femur planning model 28′. As indicated in FIGS. 5B and5C, the asymptotic line-ah can be obtained by the asymptoticdistribution, y= α+ β EXP(− μ(x− ω)), along the curvature of the lateralepicondyle 430 up to the lateral edge of femoral shaft 423 [block 1060].Similarly, the asymptotic line-bj can be obtained by the asymptoticdistribution, y= α+ β EXP(− μ(x− ω)), along the curvature of the medialepicondyle 445 up to the medial edge of femoral shaft 423 [block 1065].

As indicated in FIG. 5B, the point-k represents the center of the distalfemur shaft 423, the lowermost point in the patellofemoral surface 450.The point-i is located approximately at the midpoint between point-h andpoint-j. The lines-ik, ah are parallel, and line-ik defines the femoralanatomical axis (FAA) 455 [block 1070]. The lowest extremity of themedial epicondyle 445 is a tangent contact spot 460 that can be obtainedin FIG. 5B by a line-ef extending across tangent contact spot 460, asline-ef is perpendicular to line-ik [block 1075]. In FIG. 5B, line-hi isrelated to line-ij by the equation: hi=ij+m, where −3 mm<m<3 mm [block1080]. In some embodiments, line-ef may represent a plane-ef thatincludes line-ef and is generally perpendicular to the sagittal imageslice planes 16 used to form the restored bone model, as discussed withrespect to FIGS. 1B-1C.

ii. Landmark Reference Lines Identified Via Trochlear Groove Plane.

FIGS. 5D-5G illustrate a process in the POP wherein the system 4determines landmark reference planes via their relationship to thetrochlear groove plane-GHO of the femur restored bone model 28′ (seeFIG. 1J [block 175]). FIG. 5D is a sagittal view of a femur restoredbone model 28′ illustrating the orders and orientations of imagingslices 16 (e.g., MRI slices, CT slices, etc.) forming the femur restoredbone model 28′. FIG. 5E is the distal images slices 1-5 taken alongsection lines 1-5 of the femur restored bone model 28′ in FIG. 5D. FIG.5F is the coronal images slices 6-8 taken along section lines 6-8 of thefemur restored bone model 28′ in FIG. 5D. FIG. 5G is a perspective viewof the distal end of the femur restored bone model 28′.

In one embodiment, the identification of the trochlear groove plane-GHOmay be made during the verification of the accuracy of the bonerestoration process as disclosed in U.S. patent application Ser. No.12/111,924 to Park, which is entitled Generation of a Computerized BoneModel Representative of a Pre-Degenerated State and Usable in the Designand Manufacture of Arthroplasty Devices, was filed Apr. 29, 2008 and isincorporated by reference in its entirety into this DetailedDescription.

As shown in FIG. 5D, a multitude of image slices are compiled into thefemur restored bone model 28′ from the image slices originally formingthe femur bone model 22′ (see FIG. 1C [block 110]) and those restoredimage slices are modified via the methods disclosed in U.S. patentapplication Ser. No. 12/111,924. Image slices may extend medial-lateralin planes that would be normal to the longitudinal axis of the femur,such as image slices 1-5. Image slices may extend medial-lateral inplanes that would be parallel to the longitudinal axis of the femur,such as image slices 6-8. The number of image slices may vary from 1-50and may be spaced apart in a 2 mm spacing.

As shown in FIG. 5E, each of the slices 1-5 can be aligned verticallyalong the trochlear groove, wherein points-G1, G2, G3, G4, G5respectively represent the lowest extremity of trochlear groove for eachslice 1-5. By connecting the various points G1, G2, G3, G4, G5, apoint-O can be obtained. As can be understood from FIG. 5G, resultingline-G0, is perpendicular or nearly perpendicular to tangent line-AC. Ina 90° knee extension, line-GO is perpendicular or nearly perpendicularto the joint line of the knee and line-AC. As can be understood fromFIGS. 6A and 6B, points-A and C represent the most posterior contactpoints on the femoral condylar surfaces.

As shown in FIG. 5F, each of the slices 6-8 can be aligned verticallyalong the trochlear groove, wherein points-H6, H7, H8 respectivelyrepresent the lowest extremity of the trochlear groove for each slice6-8. By connecting the various points-H6, H7, H8, the point-O can againbe obtained. As can be understood from 5G, resulting line HO isperpendicular or nearly perpendicular to tangent line-BD. In a 0° kneeextension, line HO is perpendicular or nearly perpendicular to the jointline of the knee and line BD. As can be understood from FIGS. 6A and 6B,points-B and D represent the most distal contact points on the femoralcondylar surfaces.

As illustrated in FIG. 5G, the trochlear grove plane-GHO, as thereference across the most distal extremity of the trochlear groove ofthe femur and in a 90° knee extension, should be perpendicular totangent line AC. The line-HO, as the reference across the most posteriorextremity of trochlear groove of the femur and in a 0° knee extension,should be perpendicular to tangent line AC.

Line HO and line AC may form a plane S, and lines GO and line BD mayform a plane P that is perpendicular to plane S and forms line SRtherewith. Line HO and line G0 are parallel or nearly parallel to eachother. Lines AC, BD and SR are parallel or nearly parallel to eachother. Lines AC, BD and SR are perpendicular or nearly perpendicular tolines HO and G0 and the trochlear plane GHO.

2. Determine Elliptical Contours for Condyles of Femur Restored BoneModel.

FIGS. 6A and 6B are respective sagittal views of the lateral and medialcondyles 430, 445 of the distal femur restored bone model 28′ depictedin FIGS. 5B and 5G, wherein elliptical contours of the condyles 430, 445have been determined from the landmark reference lines depicted in FIG.5B or FIG. 5G (see FIG. 1J [block 176]). FIG. 6C is a flow chartillustrating the process of determining the elliptical contours of thecondyles 430, 445 from the landmark reference lines depicted in FIG. 5Bor FIG. 5G.

Based on plane-ef from FIG. 5B and plane-ab from FIG. 5A, or,alternatively, from plane-p from FIG. 5G and plane-s from FIG. 5G, therelated reference landmarks can be obtained on the sagittal views oflateral condyle 430 and medial condyle 445 in FIGS. 6A and 6B. As can beunderstood from a comparison of FIGS. 5A and 5G to FIGS. 6A and 6B,reference lines or planes-AE, CF are parallel to plane-ab and plane-sand respectively intersect the posterior extremity of the lateralfemoral condyle 430 and the medial femoral condyle 445 at respectivetangent spots A, C [block 1085]. As can be understood from a comparisonof FIGS. 5B and 5G to FIGS. 6A and 6B, reference planes-EB, DF areparallel to plane-ef and plane-p and respectively intersect the distalor bottom most extremity of the lateral femoral condyle 430 and themedial femoral condyle 445 at respective tangent spots B, D [block1090]. In one embodiment, in addition to being employed to identify themost distal extremities B, D and most posterior extremities A, C of theelliptical shape of the condyles, the planes-EB, DF, AE, CF may be usedto define the major elliptical axes 470, 485 and minor elliptical axes475, 490 of the elliptical shape of the condyle surfaces. These axes andpoints may be corresponded to similar axes and points of the implantmodels 34′, as described below.

As indicated in FIG. 6A, plane-AE represents the tangent of the lateralcondylar curve at the most proximal point-A, and plane-EB represents thetangent of the lateral condylar curve at the most distal point-B. Therespective tangent contact spots A, B of the planes-AE, EB define themajor axis 470 and minor axis 475 of the lateral ellipse contour 465[block 1095].

As indicated in FIG. 6B, plane-CF represents the tangent of the medialcondylar curve at the most proximal point-C, and plane-DF represents thetangent of the medial condylar curve at the most distal point-D. Therespective tangent contact spots C, D of the planes-CF, DF define themajor axis 485 and minor axis 490 of the medial ellipse contour 480[block 1100].

3. Determine Elliptical Contours for Condyles of Femur Implant and Alignin an Approximate Manner Implant Condyles to Femur Model Condyles.

FIG. 7A shows an isometric bottom view of the conventional femoralimplant model 34′ depicted in FIG. 2B. As can be understood from thefollowing discussion, the elliptical contours 505, 510 for the lateraland medial condyles 515, 520 of the femur implant model 34′ aredetermined (see FIG. 1K [block 177]). The lateral and medial condyles515, 520 of the femur implant model 34′ are then aligned in anapproximate or rough manner with the lateral and medial condyles 430,445 of the femur restored bone model 28′ (see FIG. 1K [block 178]).

FIGS. 7B and 7C are, respectively, side views of the lateral and medialsides 525, 530 of the femur implant model 34′ depicted in FIG. 7A. FIG.7D is a flow chart illustrating the method of determining ellipticalcontours 505, 510 and approximately or roughly aligning the respectivecondyles 430, 445, 515, 520 of the restored bone model 28′ with theimplant model 34′.

As indicated in FIG. 7B, the lateral femur implant condyle 515 includesan elliptical contour 505 corresponding with the outer condyle surface535. Plane-PS is tangential to the most posterior point P on the lateralouter condyle surface 535, and plane-SQ is tangential to the most distalor bottom point Q on the lateral outer condyle surface 535 [block 1105].Planes-PS, SQ, which may also be considered vectors or lines, intersecteach other at point-S and are perpendicular to each other.

As indicated in FIG. 7C, the medial femur implant condyle 520 includesan elliptical contour 510 corresponding with the outer condyle surface540. Plane-RT is tangential to the most posterior point R on the medialouter condyle surface 540, and plane-UT is tangential to the most distalor bottom point U on the medial outer condyle surface 540 [block 1110].Planes-RT, UT, which may also be considered lines or vectors, intersecteach other at point T and are perpendicular to each other.

As indicated in FIGS. 7B and 7C, points-P, R define the major axes 545,550 of the respective elliptical contours 505, 510 and minor axes 555,560 of the respective elliptical contours 505, 510 [block 1115]. Thus,planes-PS, SQ identify respectively the most posterior and distal pointson the lateral outer surface 535, and planes-RT, UT identifyrespectively the most posterior and distal points on the medial outersurface 540. Because the major and minor axes and the most distal andposterior points on the elliptical contour of the condylar surfaces canbe determined, the elliptical shape of the condylar surfaces can bemeasured and obtained.

In case of a femoral implant model 34′ with symmetric condyles 515, 520,both ellipse 505, 510 on the medial side 520 and lateral side 515 arethe same where plane-PS equals plane-RT and plane-SQ equals plane-UT. Bythe application of these planes-PS, RT, SQ, UT of the femoral implantmodel 34′, the femoral model condyles 430, 445 can be aligned to theproximity of the corresponding femoral implant condyles 515, 520 whereplane-AE is parallel to plane-PS, plane-EB is parallel to plane-SQ,plane-CF is parallel to plane-RT, and plane-DF is parallel to plane-UT[block 1120].

In one embodiment, where the trochlear groove plane is determined withrespect to the restored bone model 28′, as discussed above with respectto FIGS. 5D-5G, a similar process may be employed to find the trochleargroove plane for the femoral implant model 34′. Thus, each of the bonemodel planes-EB and DF will be perpendicular to the bone model trochleargroove plane, and each of the implant model planes-SQ and UT will beperpendicular to the implant model trochlear groove plane. In such anembodiment, plane-AE is parallel to plane-PS, plane-EB is parallel toplane-SQ, plane-CF is parallel to plane-RT, and plane-DF is parallel toplane-UT.

The relationships between the planes-AE, EB, CF and DF of the restoredbone model 28′ can be positionally correlated with the respectivecorresponding planes-PS, SQ, RT and UT of the femur implant model 34′ torefine the initial superimposing of the femur restored bone model 28′over the implant model 34′ such that the condylar surfaces 465, 480 ofthe bone model 28′ are approximately aligned with the respectivecondylar surfaces 535, 540 of the implant model 34′ prior to the shapematching process described below in this Detailed Description.

G. Shape Matching Condylar Surfaces of Restored Bone Model to CondylarSurfaces Of Femoral Implant Model.

In one embodiment, the POP system and method, once the position of thebone model and implant model is refined as described immediately above,then employs a shape match technique to match a model 34′ of anavailable femoral implant to the femoral planning or restored bone model28′. Before employing the shape match technique, it is determined if anasymmetrically modified femoral implant is selected for the POP process,or is a symmetric femoral implant is selected for the POP process (seeFIG. 1K [block 179]).

1. Asymmetrically Modified Femoral Implant Model

For a discussion regarding a POP design employing an asymmetricallymodified femoral implant model 34′, reference is made to FIGS. 8A-10.FIG. 8B shows a coronal view of a distal femur restored bone model 28′having symmetrical femoral condyles 430′, 445′. The FAA 455′ extendsthrough the center of the femur restored bone model 28′. A rotationreference line 600′ connects the lowest extremities of the two femoralcondyles 430′, 445′.

FIG. 8B depicts a joint where the size of lateral condyle 430′ issubstantially equal to the size of medial condyle 445′. In thissituation, the FAA 455′ is perpendicular or substantially perpendicularto the reference line 600′, where the offset distance td′ between thereference line 600′ and the lateral condyle 430′ is zero (i.e., td′=0)or nearly so. The offset distance td′ is the difference between themedial condyle 445′ and the lateral condyle 430′ of distal femurrestored bone model 28′.

FIG. 8A shows a coronal view of a distal femur restored bone model 28′having an asymmetrical relationship between its condyles 430, 445. Theasymmetrical relationship can be the result of the femur naturallyhaving one condyle larger than the other condyle, and depending on whichcondyle is larger, the knee will be varus or valgus. For example, it iscommon for the medial condyle 445 to be larger than the lateral condyle430. As a result, the alignment of the rotation reference line 600″relative to the FAA 455 tilts from the medial condyle 445 towards thelateral condyle 430, when the rotation reference line 600″ is not heldperpendicular to the FAA 455. Where the rotation reference line 600 isheld perpendicular to the FAA 455, an offset distance td is indicated,wherein the offset distance is the difference between the sizes of themedial and lateral condyles 445, 430.

As shown in FIG. 8A, with respect to FAA 455, the lateral condyle 430 issmaller than the medial condyle 445, leaving an offset distance td whenreference line 600 is maintained perpendicular to the FAA 455, asopposed to tilting against the surfaces of both condyles 430, 445, asdepicted by reference line 600″. The offset distance td is thedifference between the medial condyle 445 and lateral condyle 430 of thedistal femur model 28′. Depending on the direction of the tilt and whichcondyle 430, 445 is smaller, the result is a varus deformity or a valgusdeformity. The femoral condyle or offset difference td in FIG. 8A variesdepending on the amount natural difference between the medial andlateral condyles 445, 430.

As can be understood from FIG. 8A and FIG. 9C, which is a flow chartdepicting the method of shape fitting with an asymmetrically modifiedimplant model 34′, where the system 4 determines the femur model 28′ hasasymmetrical condyles 430, 445, the system 4 will determine the offsetdifference td between the condyles 430, 445 [block 1125].

FIGS. 9A and 9B are, respectively, an isometric view of a symmetricimplant model 34′ and a lateral side view of the implant model 34′ afterbeing asymmetrically modified. As indicated in FIG. 9A, prior to beingasymmetrically modified, the symmetric implant model 34′ has symmetricallateral and medial condyles 515, 520 with articulating surfaces 535, 540that are nearly the same size. In order to modify the symmetric implantmodel 34′ to fit the asymmetrical nature of bone model 28′, the lateralcondylar articulating surface 535 of the symmetrical implant model 34′is moved proximally, as indicated by arrow 605, along the FAA 455 theoffset distance td measured on the femur model 34′ in FIG. 8A [block1130].

FIG. 10 is a coronal view of the femur model 28′ and the asymmetricalimplant model 34′ aligned along the FAA 455, which serves as thereference axis for rotational and translation alignment between thefemur and implant models 28′, 34′. As shown in FIG. 10, due to theasymmetric condyle configuration depicted in FIG. 8A, the femoralcondyle difference td in FIGS. 8A and 9B is shown in each of the femurmodel 28′ and the correspondingly asymmetrically modified implant model34′. The lowest extremity of tangent contact spots A′ and B′ are knowfrom the tangent plane procedures described above in this DetailedDescription. Also, the information pertaining to FAA and td are knownfrom the above described procedures.

As can be understood from FIG. 10, the lowest extremity of tangentcontact spots A and B for the implant model 34′ can be identified ineach of the distal medial condylar articulating surface 540 and thedistal lateral condylar articulating surface 535, respectively [block1135]. The FAA and td for the implant model 34′ are determined from thebone model 28′, and the lowest extremities A and B of the implant modelcondylar surfaces may be measured.

Because the line-AB connecting point-A and point-B is titled relative tothe reference line 600, an angle θ can be obtained where θ=tan⁻¹(td/L)and L is the distance along the reference line 600 between points A andB [block 1140]. The value for angle θ can be stored in a database 15 ofthe system 4 and further applied to a symmetric femoral implantalignment after the shape matching technique described below withrespect to FIGS. 16-19 in this Detailed Description [block 1145]. Afterthe shape matching technique, in order to achieve accurate alignment androtation between the femur model 28′ and a symmetric implant model 34′representative of an actual implant provided by an implant manufacturer,the femur model 28′ of FIG. 10 will be superposed to the symmetricimplant model 34′ with a rotation of angle θ with respect to point B inFIG. 10 [block 1150].

2. Symmetrical Femoral Implant

For a discussion regarding a POP design employing an symmetrical femoralimplant model 34′, reference is made to FIGS. 11A and 11B. FIG. 11A is acoronal view of the asymmetrical femur model 28′ and the symmetricalimplant model 34′. FIG. 11B is a flow chart illustrating the method ofshape fitting with the symmetrical implant model 34′.

As indicated in FIGS. 11A and 11B, the lowest extremity of tangentcontact spots B and A are identified on each of the medial condyle 445and lateral condyle 430, respectively [block 1155]. The line-MN extendsacross the two lowest extremity points-A, B and is presumed to beparallel to the joint line of the knee in a knee kinetics study. In oneembodiment, the line 455 may represent the trochlear groove axis (plane,line or vector direction OP) reference. The line-MN may be perpendicularor generally perpendicular to the trochlear groove axis-455. Similarly,in the symmetrical femoral implant model 34′, the lowest extremity oftangent contact spots D and C can be identified in each of the distalmedial condylar articulating surface 540 and the distal lateral condylararticulating surface 535, respectively [block 1160]. With reference tothe trochlear groove axis 455 (i.e., plane, line or vector directionOQ), the line across points-C, D and perpendicular to reference line 455is defined as line or plane RS. To rotationally and translationallyalign the femur model 28′ and the symmetric implant model 34′, place thefemur model 28′ onto the symmetric implant model 34′ such that plane MNis parallel to plane RS and plane OP is parallel to plane OQ [block1165].

3. Determining Joint Line and Adjustment to Surface Matching that AllowsSurface Matching of Implant Model Condylar Surfaces to Restored BoneModel Condylar Surfaces to Restore Joint to Natural Configuration.

In order to allow an actual physical arthroplasty implant to restore thepatient's knee to the knee's pre-degenerated or natural configurationwith the its natural alignment and natural tensioning in the ligaments,the condylar surfaces of the actual physical implant generally replicatethe condylar surfaces of the pre-degenerated joint bone. In oneembodiment of the systems and methods disclosed herein, condylarsurfaces of the restored bone model 28′ are surface matched to thecondylar surfaces of the implant model 34′. However, because therestored bone model 28′ may be bone only and not reflect the presence ofthe cartilage that actually extends over the pre-degenerated condylarsurfaces, the surface matching of the modeled condylar surfaces may beadjusted to account for cartilage or proper spacing between the condylarsurfaces of the cooperating actual physical implants (e.g., an actualphysical femoral implant and an actual physical tibia implant) used torestore the joint such that the actual physical condylar surfaces of theactual physical cooperating implants will generally contact and interactin a manner substantially similar to the way the cartilage coveredcondylar surfaces of the pre-degenerated femur and tibia contacted andinteracted.

Thus, in one embodiment, the implant model is modified or positionallyadjusted to achieve the proper spacing between the femur and tibiaimplants. To achieve the correct adjustment, an adjustment value tr maybe determined (see FIG. 1K [block 180]). In one embodiment, theadjustment value tr that is used to adjust the surface matching may bebased off of an analysis associated with cartilage thickness. In anotherembodiment, the adjustment value tr used to adjust the surface matchingmay be based off of an analysis of proper joint gap spacing. Both of themethods are discussed below in turn.

i. Determining Cartilage Thickness and Joint Line

FIG. 12 shows the sagittal view MRI slice of the femoral condyle 615 andthe proximal tibia of the knee in a MRI image slice. The distal femur620 is surrounded by the thin black rim of cortical bone. Due to thenature of irregular bone and cartilage loss in OA patients, it can bedifficult to find the proper joint line reference for the models usedduring the POP.

The space between the elliptical outlining 625′, 625″ along the corticalbone represents the cartilage thickness of the femoral condyle 615. Theellipse contour of the femoral condyle 615 can be seen on the MRI sliceshown in FIG. 12 and obtained by a three-point tangent contact spot(i.e., point t1, t2, t3) method. This three-point contact spot method isillustrated with respect to FIGS. 14A-14D, and its purpose is to“restore” the joint line reference. In a normal, healthy knee, the bonejoint surface is surrounded by a layer of cartilage. Because thecartilage is generally worn-out in OA and the level of cartilage lossvaries from patient to patient, it may be difficult to accuratelyaccount for the cartilage loss in OA patients when trying to restore thejoint via TKA surgery. Therefore, in one embodiment of the methodologyand system disclosed herein, a minimum thickness of cartilage isobtained based on medical imaging scans (e.g., MRI, etc.) of theundamaged condyle. Based on the cartilage information, the joint linereference can be restored. For example, the joint line MN identifiedabove may be line 630 in FIG. 13.

The system and method disclosed herein provides a POP method tosubstantially restore the joint line back to a “normal or natural knee”status (i.e., the joint line of the knee before OA occurred) andpreserves ligaments in TKA surgery (e.g., for a total knee arthroplastyimplant) or partial knee arthroplasty surgery (e.g., for a uni-kneeimplant).

FIG. 13 is a coronal view of a knee model in extension. As depicted inFIG. 13, there are essentially four separate ligaments that stabilizethe knee joint, which are the medial collateral ligament (MCL), anteriorcruciate ligament (ACL), lateral collateral ligament (LCL), andposterior cruciate ligament (PCL). The MCL and LCL lie on the sides ofthe joint lie and serve as stabilizers for the side-to-side stability ofthe knee joint. The MCL is a broader ligament, whereas the LCL is adistinct cord-like structure.

The ACL is located in the front part of the center of the joint. The ACLis a very important stabilizer of the femur on the tibia and serves toprevent the tibia from rotating and sliding forward during agility,jumping, and deceleration activities. The PCL is located directly behindthe ACL and the tibia from sliding to the rear. The system and methoddisclosed herein provides POP that allows the preservation of theexisting ligaments without ligament release during TKA surgery. Also,the POP method provides ligament balance, simplifying TKA surgeryprocedures and reducing pain and trauma for OA patients.

As indicated in FIG. 13, the joint line reference 630 is defined betweenthe two femoral condyles 430, 445 and their corresponding tibia plateauregions 635, 640. Area A illustrates a portion of the lateral femoralcondyle 430 and a portion of the corresponding lateral plateau 635 oftibia 205. Area 13 illustrates the area of interest showing a portion ofthe medial femoral condyle 445 and a portion of the corresponding medialplateau 640 of tibia 205.

FIGS. 14A, 14B and 14D illustrate MRI segmentation slices for joint lineassessment. FIG. 14C is a flow chart illustrating the method fordetermining cartilage thickness used to determine proper joint line. Thedistal femur 200 is surrounded by the thin blank rim of cortical bone645. The cancellous bone (also called trabecular bone) 650 is an innerspongy structure. An area of cartilage loss 655 can be seen at theposterior distal femur. For OA patients, the degenerative cartilageprocess typically leads to an asymmetric wear pattern that results onefemoral condyle with significantly less articulating cartilage than theother femoral condyle. This occurs when one femoral condyle isoverloaded as compared to the other femoral condyle.

As can be understood from FIGS. 14A and 14C, the minimum cartilagethickness is observed and measured for the undamaged and damaged femoralcondyle 430, 445 [block 1170]. If the greatest cartilage loss isidentified on the surface of medial condyle 445, for example, then thelateral condyle 430 can be used as the cartilage thickness reference forpurposes of POP. Similarly, if the greatest cartilage loss is identifiedon the lateral condyle 430, then the medial condyle 445 can be used asthe cartilage thickness reference for purposes of POP. In other words,use the cartilage thickness measured for the least damaged condylecartilage as the cartilage thickness reference for POP [block 1175]

As indicated in FIG. 14B, the thickness of cartilage can be analyzed inorder to restore the damaged knee compartment back to its pre-OA status.In each of the MRI slices taken in regions A and 13 in FIG. 13, thereference lines as well as the major and minor axes 485, 490 of ellipsecontours 480′, 480″ in one femoral condyle 445 can be obtained.

As shown in FIG. 14D, for the three-point method, the tangents are drawnon the condylar curve at zero degrees and 90 degrees articular contactpoints. The corresponding tangent contact spots t1′ and t2′ are obtainedfrom the tangents. The line 1450 perpendicular to the line 1455determines the center of the ellipse curve, giving the origin of (0, 0).A third tangent contact spot t3′ can be obtained at any point along theellipse contour between the 90 degree, t1 point and the zero degree, t2′point. This third spot t3′ can be defined as k, where k=1 to n points.

The three-point tangent contact spot analysis may be employed toconfigure the size and radius of the condyle 445 of the femur restoredbone model 28′. This provides the “x” coordinate and “y” coordinate, asthe (x, y) origin (0, 0) shown in FIG. 14B. The inner ellipse model 480′of femoral condyle shows the femoral condyle surrounded by cortical bonewithout the cartilage attached. The minimum cartilage thickness tm_(min)outside the inner ellipse contour 480′ is measured. Based on theanalysis of the inner ellipse contour 480′ (i.e., the bone surface) andouter ellipse contour 480″ (i.e., the cartilage surface) of the onenon-damaged condyle of the femur restored bone model 28′, the innerellipse contour 480′ (i.e., the bone surface) and the outer ellipsecontour 480″ (i.e., the cartilage surface) of the other condyle (i.e.,the damage or deteriorated condyle) may be determined.

As can be understood from FIGS. 13 and 14B, ellipse contours 480′, 480″are determined in areas A and B for the condyles 430, 445 of the femurrestored bone model 28′. The inner ellipse contour 480′, representingthe bone-only surface, and the outer ellipse contour 480″, representingthe bone-and-cartilage surface, can be obtained. The minimum cartilagethickness tm_(min) is measured based on the cartilage thickness trbetween the inner ellipse 480′ and outer ellipse 480″. MRI slices of thetwo condyles 430, 445 of the femur restored bone model 28′ in areas Aand B are taken to compare the respective ellipse contours in areas Aand B. If the cartilage loss is greatest for at the medial condyle 445in the MRI slices, the minimum thickness tm_(min) for the cartilage canbe obtained from the lateral condyle 430. Similarly, if the lateralcondyle 430 has the greatest cartilage loss, the cartilage thicknesstm_(min) can be obtained from undamaged medial condyle 445 of the femurrestored bone model 28′. The minimum cartilage can be illustrated in theformula, tm_(min)=MIN (ti), where i=1 to k.

ii. Determining Joint Gap

As mentioned above, in one embodiment, the adjustment value tr may bedetermined via a joint line gap assessment. The gap assessment may serveas a primary estimation of the gap between the distal femur and proximaltibia of the restored bone model. The gap assessment may help achieveproper ligament balancing.

In one embodiment, an appropriate ligament length and joint gap may notbe known from the restored bone models 28′, 28″ (see FIG. 2A) as therestored bone models may be oriented relative to each other in a fashionthat reflects their deteriorated state. For example, as depicted in FIG.14H, which is a coronal view of restored bone models 28′, 28″ oriented(e.g., tilted) relative to each other in a deteriorated stateorientation, the lateral side 1487 was the side of the deteriorationand, as a result, has a greater joint gap between the distal femur andthe proximal tibia than the medial side 1485, which was thenon-deteriorated side of the joint in this example.

In one embodiment, ligament balancing may also be considered as a factorfor selecting the appropriate implant size. As can be understood fromFIG. 14H, because of the big joint gap in the lateral side 1487, thepresumed lateral ligament length (L1+L2+L3) may not be reliable todetermine proper ligament balancing. However, the undamaged side, whichin FIG. 14H is the medial side 1485, may be used in some embodiments asthe data reference for a ligament balancing approach. For example, themedial ligament length (M1+M2+M3) of the undamaged medial side 1485 maybe the reference ligament length used for the ligament balancingapproach for implant size selection.

In one embodiment of the implant size selection process, it may beassumed that the non-deteriorated side (i.e., the medial side 1485 inFIG. 14H in this example) may have the correct ligament length forproper ligament balancing, which may be the ligament length of(M1+M2+M3). When the associated ligament length (“ALL”) associated witha selected implant size equals the correct ligament length of(M1+M2+M3), then the correct ligament balance is achieved, and theappropriate implant size has been selected. However, when the ALL endsup being greater than the correct ligament length (M1+M2+M3), theimplant size associated with the ALL may be incorrect and the nextlarger implant size may need to be selected for the design of thearthroplasty jig 2.

For a discussion regarding the gap assessment, which may also be basedon ligament balance off of a non-deteriorated side of the joint,reference is made to FIGS. 14D and 14F. FIGS. 14E and 14F illustratecoronal views of the restored bone models 28′, 28″ in theirpost-degeneration alignment relative to each as a result of OA orinjury. As shown in FIG. 14E, the restored tibia model 28″ is titledaway from the lateral side 1487 of the knee 1486 such that the joint gapbetween the femoral condylar surfaces 1490 and the tibia condylarsurfaces 1491 on the lateral side 1487 is greater than the joint gap onthe medial side 1485.

As indicated in FIG. 14F, which illustrates the tibia in a coronal crosssection, the line 1495 may be employed to restore the joint line of theknee 1486. The line 1495 may be caused to extend across each of lowestextremity points 1496, 1497 of the respective femoral lateral and medialcondyles 1498, 1499. In this femur restored bone model 28′, line 1495may be presumed to be parallel or nearly parallel to the joint line ofthe knee 1486.

As illustrated in FIG. 14F, the medial gap Gp2 represents the distancebetween the distal femoral medial condyle 1499 and the proximal tibiamedial plateau 1477. The lateral gap Gp1 represents the distance betweenthe distal femoral lateral condyle 1498 and the proximal tibia lateralplateau 1478. In this example illustrated in FIG. 14F, the lateral gapGp1 is significantly larger than the medial gap Gp2 due to degenerationcaused by injury, OA, or etc. that occurred in the lateral side 1487 ofthe knee 1486. It should be noted that while the bone models 28′, 28″have surface configurations that have been restored such that the bonemodels 28′, 28″ are restored bone models 28′, 28″, the alignment of thebone models 28′, 28″ relative to each other for the example illustratedin FIGS. 14E and 14F depict the alignment the actual bones have relativeto each other in a deteriorated state. To restore the joint linereference and maintain ligament balancing for the medial collateralligament (MCL) and lateral collateral ligament (LCL), the joint line gapGp3 that is depicted in FIG. 14G, which is the same view as FIG. 14E,except with the joint line gap Gp3 in a restored state, may be used forthe shape matching adjustment as described below. As illustrated in FIG.14G, the lines 1495 and 1476 respectively extend across the most distalcontact points 1496, 1497 of the femur condyles 1498, 1499 and the mostproximal contact points 1466, 1467 of the tibia plateau condyles 1477,1478.

For calculation purposes, the restored joint line gap Gp3 may be whichever of Gp1 and Gp2 has the minimum value. In other words, the restoredjoint line gap Gp3 may be as follows: Gp3=MIN (Gp1, Gp2). For purposesof the adjustment to the shape matching, the adjustment value tr may becalculated as being half of the value for Gp3, or in other words,tr=Gp3/2. As can be understood from FIGS. 14E-14F and 14H, in thisexample, the non-deteriorated side 1485 has Gp2, which is the smallestjoint line gap and, therefore, Gp3=Gp2 in the example depicted in FIG.14E-14H, and tr=Gp2/2.

In one embodiment, the joint line gap assessment may be at least a partof a primary assessment of the geometry relationship between the distalfemur and proximal tibia. In such an embodiment, the joint gapassessment step may occur between [block 173] and [block 174] of FIG.1J. However, in other embodiments, the joint line gap assessment mayoccur at other points along the overall POP process.

4. Adjust Femoral Implant to Account for Joint Gap or CartilageThickness.

Once the adjustment value tr is determined based off of cartilagethickness or joint line gap Gp3, the femoral implant model 34′ can bemodified or adjusted to account for cartilage thickness to restore thejoint line (see FIG. 1K [block 181]. FIGS. 15A and 15B are,respectively, an isometric view and a lateral side view of the modifiedfemoral implant model 34′.

As can be understood from FIGS. 15A and 15B, the modification of femoralimplant model 34′ occurs below line KJ in FIG. 15B. The inner ellipticalbone surface model 480′ and the outer elliptical cartilage surface model480″ in FIG. 14B can be illustrated in the each of formula (1) andformula (2), respectively:

$\begin{matrix}{{\frac{( {x - x} )^{2}}{p^{2}} + \frac{( {y - y} )^{2}}{q^{2}}} = 1} & {{Formula}\mspace{14mu} (1)} \\{{\frac{( {x - x} )^{2}}{r^{2}} + \frac{( {y - y} )^{2}}{s^{2}}} = 1} & {{Formula}\mspace{14mu} (2)}\end{matrix}$

where P=wr, q=ws, and 0<w<1, wherein when p=q the result is a circlecurve and when p≠q the result is an ellipse curve. Via the adjustmentvalue tr, a restored condylar shape may be obtained by using the ellipsemodel and the mathematical information described above. The outerellipse 480″ may be attached with the adjustment value tr, which may berepresentative of cartilage thickness or half of the restored joint gapGp3, and the inner ellipse 480′ may be the bone contour withoutcartilage extending about the bone contour. The inner and outer ellipse480′, 480″ may differ in a ratio of w factor, where 0<w<1. Based on thew factor, the p radius is smaller than radius r in a ratio of w. Asimilar analogy applies for radius q, where q is smaller than s in aratio of w.

As best illustrated in FIG. 15B, the femoral implant model 34′ includesan upper or distal-anterior part 670 and a lower or distal-posteriorpart 675 separated by the line KJ. The upper or distal-anterior part 670of femoral implant model 34′ comprises an external anterior-distalarticular surface 680 and a multi-faced interior anterior-distalnon-articular surface 685. The interior anterior-distal non-articularsurface 685 includes an anterior non-articular surface 690 and adistal-anterior non-articular surface 695.

A distal portion 696 of the distal-anterior non-articular surface 695may be a plane generally perpendicular to a natural alignment verticallyextending axis when the actual physical implant is mounted on the distalfemur end as part of an arthroplasty procedure. An anterior chamferedportion 697 of the distal-anterior non-articular surface 695 may be aplane having a generally chamfered relationship to the distal portion696.

The distal portion 696 of the distal-anterior non-articular surface 695may abut against the first distal planar resection formed in the distalfemur end during the arthroplasty procedure. The first distal planarresection may act as a guide from which other resections (e.g., theposterior and anterior chamfer resections) are referenced. The anteriorchamfered portion 697 of the distal-anterior non-articular surface 695may abut against the anterior planar resection formed in the distalfemur end during the arthroplasty procedure. Thus, the interioranterior-distal non-articular surface 685 is adapted to receive theanterior flange of a resected distal femur.

The lower or distal-posterior part 675 of femoral implant model 34′includes an external posterior-distal articular surface 700 and amulti-faced interior posterior-distal non-articular surface 705. Theexternal posterior-distal articular surface 700 includes the medialdistal-posterior condylar articulating surface 540 and the lateraldistal-posterior condylar articulating surface 535. The lower ordistal-posterior part 675 of femoral implant model 34′ is modified toaccount for the adjustment value tr, which may be based on the cartilagethickness or half of the restored joint gap Gp3. In one embodiment, theadjustment value tr is applied in both a posterior-anterior directionand a distal-proximal direction to the lower or distal-posterior portion675 of the implant model 34′

As can be understood from FIGS. 15A and 15B, the condyle surface 535modified to account for the damaged bone and cartilage loss isdimensioned smaller than the condyle surface 540 for the non-damagedbone by a factor w in both the distal and posterior portions, wherein wequals the adjustment thickness tr. With the study of the cartilagethickness or restored joint gap Gp3, the system 4 can provide therestoration of cartilage and therefore assess the joint line for thedistal femur model 28′.

5. Shape Matching of Condyle Surfaces of Restored Femoral Bone Model toCondyle Surfaces of Femoral Implant Model.

FIG. 16 is an isometric view of a femoral implant model 34′ being shapematched to a femur planning model 28′ (see FIG. 1K [block 182]). Asshown in FIG. 16, the femur implant model 34′ is direct surface matchedonto the surface of the restored femur bone model 28′ such that thearticular surface profile of the femoral implant model 34′ is matched tothe articular surface profile of the femoral condyles 430, 445 of thefemur restored bone model 28′. The function s (x, y, z) represents thesurface profiles 720, 725 for each of the exterior distal-posteriorarticular surfaces 700 of the lower or distal-posterior part 675 of theimplant model 34′ in FIG. 15B. The function h (x, y, z) represents thearticular surface profile of a femoral condyle 430, 445 of the lower ordistal-posterior part of a femur restored bone model 28′ as it would beif line KJ of FIG. 15B were applied to a femur restored bone model 28′situated similar to the implant model 34′ in FIG. 15B.

In one embodiment, the surface models 720, 725 may displacemedial-lateral relative to each other, but are constrained to move witheach other in all other directions. For example the surface models 720,725 may displace closer or further apart to each other along the x-axis,but are matched to displace along the y-axis and z-axis as a set andfixed relative to each other.

The function ē(x,y,z) represents a true vector assuming that templatenoise is independent of the implant surface profile noise. The problemis estimating the parameters of a 3D transformation that satisfies theleast squares fit surface matching of the implant condyle articularsurface profile s (x, y, z) to the femoral condyle articular surfaceprofile h (x, y, z). This can be achieved by minimizing a goal function,which measures the sum of squares of the Euclidean distances betweenthese two surface profiles, represented by ē(x,y,z)=h(x,y,z)−s(x,y,z).For greater detail regarding this operation, see the followingpublications, which are incorporated by reference in their entiretiesinto this Detailed Description: D. Akca, Matching of 3D Surfaces andTheir Intensities, ISPRS Journal Of Photogrammetry & Remote Sensing, 62(2007), 112-121; and Gruen A. et al., Least Squares 3D surface and CurveMatching, ISPRS Journal of Photogrammetry & Remote Sensing 59 (2005),151-174.

As an option to the process discussed with respect to FIGS. 15A 16, thefemur implant model 34′ can be directly shape matched onto the femurrestored bone model 28′ as described in the following discussion. FIGS.17A and 17B are isometric views of an ellipsoid model 730 of a femoralcondyle 430, 445 obtained through a plurality of MRI slices taken in amanner similar to the MRI slice depicted in FIG. 12 and from areas A andB in FIG. 13. Each of the femoral condyles 430, 445 in FIG. 13 consistsof a series of ellipses in areas A and B. Therefore, the 3D ellipsoidmodel 730 of the condyles 430, 445 can be reconstructed by repetitiveimage analysis through a plurality of MRI slices taken through areas Aand B in FIG. 13 in a manner similar to the MRI slice depicted in FIG.12. As shown in FIG. 17B, a portion 735 of the femoral condyle model 730can be segmented and removed from the rest of the model 730.

FIG. 18 is an isometric view depicting the 3D surface matching using thecondyle models 730 of FIGS. 17A and 17B. The surface matching techniqueprovides varus/valgus and information for the femoral implant planningdesign. The drilling hole of the femur implant model 34′ and thesurgical cut plane SCP of the femur implant model 34′ provide theinformation for the IR/ER rotation. In FIG. 18, each of the ellipsoidmodel 735, 735′ represents the femoral condyles 430, 445 of the distalfemur restored bone model 28′. The ellipsoid condylar portions 735, 735′are each taken out from the 3D models 730, 730′. The ellipsoid equationin model 730′ can be illustrated as

${\frac{( {x - x} )^{2}}{p_{2}^{2}} + \frac{( {y - y} )^{2}}{q_{2}^{2}} + \frac{( {z - z} )^{2}}{r_{2}^{2}}} = 1.$

The ellipsoid equation in model in 730 can be illustrated as

${\frac{( {x - x} )^{2}}{p_{1}^{2}} + \frac{( {y - y} )^{2}}{q_{1}^{2}} + \frac{( {z - z} )^{2}}{r_{1}^{2}}} = 1.$

The surface models of ellipsoid condylar portions 735, 735′ can beobtained from these two ellipsoid equations. These two portions 735,735′ correspond to the distal-posterior portions of each condyle 430,445 of the distal femur surface model 28′. In the femur model 28′, thefunction f (x, y, z) represents a portion of ellipsoid surface of modelportion 735, approximately describing the distal-posterior bone surfaceof the medial condyle 445. Similarly, the function f′ (x, y, z)represents a portion of ellipsoid surface of model portion 735′,approximately describing the distal-posterior bone surface of thelateral condyle 430.

The function s (x, y, z) represents the surface model 725 of the medialdistal-posterior exterior articular surface 700 of the lower ordistal-posterior part 675 of femoral implant model 34′ in FIG. 15B. Thes′ (x, y, z) represents the surface model 720 of lateraldistal-posterior exterior articular surface 700 of the lower ordistal-posterior part 675 of femoral implant model 34′ in FIG. 15B.

In one embodiment, the surface models 720, 725 may displacemedial-lateral relative to each other, but are constrained to move witheach other in all other directions. For example the surface models 720,725 may displace closer or further apart to each other along the x-axis,but are matched to displace along the y-axis and z-axis as a set andfixed relative to each other.

The function e(x, y, z) represents a true vector assuming that templatenoise is independent of the implant surface profile noise. Theparameters of a 3D transformation satisfy the least squares matching ofthe interior surface profile (x, y, z) of the implant to the ellipsoidpotions surface profile f (x, y, z) of the femoral condyle. Similarly,the e(x, y, z) represents the least squares matching of the interiorsurface profile s′ (x, y, z) of the implant to the ellipsoid potionssurface profile f′(x, y, z) of the femoral condyle. This can be achievedby minimizing a goal function, which measures the sum of squares of theEuclidean distances between the two surface profiles, represented bye(x,y,z)=f(x,y,z)−s(x,y,z), and e′(x,y,z)=f′(x,y,z)−s′(x,y,z), whereJ=MIN (e(x,y,z)), and J′=MIN (e′(x,y,z)). See D. Akca (supra). Thevalgus/varus and IR/ER of the original joint line has now been restored.

6. Aligning with Respect to Rotation and Translation the ModifiedFemoral Implant Model to the Femur Model

FIG. 19A shows the sagittal view of inaccurate rotation alignmentbetween the anterior flange 750 of a modified femoral implant model 34′and the anterior distal femur restored bone model 28′. FIG. 19B showsthe sagittal view of correct rotation alignment between the anteriorflange 750 of the modified femoral implant model 34′ and the anteriordistal femur restored bone model 28′.

As previously discussed with respect to FIGS. 15A and 15B, thedistal-anterior part 670 of the modified femoral implant model 34′includes an external anterior-distal articular surface 680 and aninterior anterior-distal non-articular surface 685. The interioranterior-distal non-articular surface 685 includes the anteriornon-articular surface 690 and the distal anterior non-articular surface695. The sizes of distal-anterior part 670 of the modified femoralimplant model 34′ are selected from the femoral implants currentlyavailable from implant manufactures and according to the methoddiscussed with respect to the bAP and bML extents of femur planningmodel 28′ in FIGS. 3A-3C.

As can be understood from a comparison of FIG. 19A to FIG. 19B, thedistal femur restored bone model 28′ is rotated a certain number ofdegrees so the interior anterior-distal non-articular surface 685 can beadapted to meet the anterior cortex of distal femur restored bone model28′, while points M and N are preserved as much as possible to minimizeerror. The extent to which the femur model restored bone model 28′ isrotated relative to the implant model 34′ can be understood from acomparison of the FAA 455 in FIGS. 19A and 19B.

By employing the three-point tangent contact spot method (i.e., pointsM, N, and any points between M and N), the minimum degree of error A° isachieved. The degree of error A° is based on the limitation of availablesizes of commercial implants, where 0<A°<20°. For example, some implantmanufacturers only make available eight sizes of femoral implants. Ifthe patient's femur bAP extent is greater than the iAP extent of theselected implant size, while the bML is approximately equal to iML, thenapplying the model 34′ of the selected implant to align with thepatient's femur restored bone model 28′ will cause an error of degree A°that is larger than a 20° rotation alignment range. In this case it issuggested to choose the next bigger size of implant to minimize thedegree of error.

As can be understood from FIGS. 7A, 7B, 15B and 19B, once thedistal-posterior articular surfaces 700 of the implant model 34′ areshape matched to the corresponding distal-posterior articular surfacesof the restored femur bone model 28′, the distal portion 696 of thedistal-anterior non-articular surface 695 will be superposed in thefemur restored bone model 28′ to indicate a location of a distalsurgical cut plane or distal resection plane SCP that will correspond toa saw cut slot 123 (see FIGS. 1F and 1G) in the femur arthroplasty jig2A that can be used to create the first distal planar resection formedin the distal femur end during the arthroplasty procedure. As theposterior-distal articular surface 700 is adjusted for the adjustmentvalue tr for the shape matching process, the SCP ends up being locateddistally further by the amount of the adjustment value tr than it wouldotherwise be, resulting in the actual physical implant when mounted onthe actual distal femur end providing articular surfaces that arepositioned and oriented so as to allow the patient's knee to assume anatural or non-degenerated configuration.

The orientation and location of the implant's mounting post P (see FIG.7B) may also be determined once the implant model 34′ and restored bonemodel 28′ are superposed. Also, the locations and orientations of thedrill holes 124 (see FIGS. 1F and 1G) of the arthroplasty jig 2A may bedetermined from the implant model 34′ and restored bone model 28′ beingsuperposed.

Once the shape match process (see FIG. 1K [block 182] and FIG. 1C [block120]) is complete, the information regarding the locations andorientations for the saw cut slot 123 and drill holes 124 may bepackaged as saw cut and drill hole data 44 (see FIG. 1E [block 125]) andthe process goes forward as outlined in FIG. 1E.

H. Determining Areas of Interest A, B for Tibia Plateau Corresponding toAreas of Interest A, B for the Femoral Condyles

FIG. 20 is a plan or top view of the plateau of the tibia restored bonemodel 28″. As shown in FIG. 20, areas of interest A and B, which aresimilar to those depicted on the femur condyles 430, 445 in FIG. 13, areidentified on the surface of lateral plateau 760 and medial plateau 765of tibia restored bone model 28″ (see FIG. 1J [block 183]). The surfaceshape of the medial plateau 765 is incongruent with the lateral plateau760. The lateral plateau 760 shows a roughly flat surface. The medialplateau 765 shows a roughly concaved recess. The areas A and B of focuson portions of the medial and lateral plateau surfaces 765, 760. Theareas A and B represent the contact areas around the joint line forarticulatingly receiving the corresponding respective distal surfaces ofthe femoral medial and lateral condyles 445, 430 identified in FIG. 13.

I. Determining Reference Points for Tibia Plateau

As with the identification of the distal reference points at the mostdistal points of the femoral condyle articular surfaces, as discussedabove, corresponding reference points are identified on the tibiaplateaus (see FIG. 1J [block 184]). As may be understood from thefollowing discussion, the reference points for the tibia plateaus may belocated at the lowest or most distally recessed points in eachrespective plateau.

FIGS. 21A-C illustrate the initial varus/valgus position of the tibiarestored bone model 28″ and the tibia implant model 34″. FIG. 21A is aMRI image slice 16 of the medial portion 765 of the proximal tibia usedto form the tibia restored bone model 28″ and indicates theestablishment of landmarks for the tibia POP design. The joint line maybe assessed as described above with respect to FIGS. 12-14F. The surfacecontour of the medial plateau 765 is outlined along the tibia meniscusstarting from a portion of the anterior medial surface to a posteriormedial surface as shown in FIG. 21A. The reference spot S is selectedand located approximately in the midpoint of the surface contour of thetibia medial plateau 765. The reference spot S is located within thearea of interest B in FIG. 20 and may be the most distally recessedpoint within area B.

FIG. 21B is a MRI image slice 16 of the lateral portion 760 of theproximal tibia used to form the tibia restored bone model 28″. Thesurface contour of lateral plateau 760 is outlined along the tibiameniscus starting from a portion of the anterior lateral surface to theposterior lateral surface. The reference spot V is selected and locatedapproximately in the midpoint of the surface contour of the tibialateral plateau 760. The reference spot V is located within the area ofinterest A in FIG. 20 and may be the most distally recessed point withinarea A.

In each of the MRI slices 16, the landmarks as well as the origin O ofthe medial and lateral tibia plateaus 765, 760 for IR/ER rotation andalignment of the tibia implant model 34″ can be obtained. Amedial-lateral extending line connecting both spots S, V can be madewhich is parallel to the joint line or parallel to a reference Z-axis ofthe X-Y axis indicated in FIGS. 21A and 21B. In the slices 16 depictedin FIGS. 21A and 21B, the length of line I1 equals the length of lineI2. In other words, the respective distances of each point S and V fromthe origin O along the y-axis are equal. This provides an “x” coordinateand a “y” coordinate, as the (x, y) origin O has a coordinate of (0, 0),as shown in FIGS. 21A and 21B. The plane formed by the x-axis and z-axis(i.e., the plane perpendicular to the x-y plane) is parallel to thejoint line. Corresponding reference points S′, V′ are indicated on thelateral and medial plateaus 770, 775 of the implant model 34″, which isdepicted in FIG. 21C as an isometric view.

In FIG. 21C, the tangent or reference points S′, V′ represent themidpoints of the respective surfaces of the medial tibia plateau 775 andthe lateral tibia plateau 770. These two points S′, V′ are located inthe respective areas of interest described in FIG. 20. Also, each pointS′, V′ may represent the most distally recessed point in the respectivetibia plateau 775, 770. A vector direction line-212 extends acrosspoint-S′ in medial tibia plateau 775. A vector direction line-216extends across point-V′ in the lateral tibia plateau 770. The vector-212is parallel or generally parallel to vector-216, and is about the sameheight with vector-216. The line-S′V′ extends across points-S′ and V′and can be obtained. This line-S′V′ is parallel or generally parallel tothe joint line of the knee.

As can be understood from FIGS. 21A-21C, the midpoints S, V in themedial plateau 765 and lateral plateau 760 of tibia 205 coincide withthe points S′, V′ located approximately at the centre of the medial andlateral bearing surfaces 775, 770 of the tibia implant model 34″. Asindicated in FIG. 21C, the tibia implant 34″ includes a base member 780for being secured to the proximal tibia 28″. The line across the pointsS′, V′ of tibia implant 34″ is parallel to the joint line and, parallelto the X-axis of the MRI slices of FIGS. 21A and 21B.

J. Determining Joint Line and Adjustment to Surface Matching That AllowsSurface Matching of Implant Model Condylar Surfaces to Restored BoneModel Condylar Surfaces to Restore Joint to Natural Configuration.

In order to allow an actual physical arthroplasty implant to restore thepatient's knee to the knee's pre-degenerated or natural configurationwith its natural alignment and natural tensioning in the ligaments, thecondylar surfaces of the actual physical implant generally replicate thecondylar surfaces of the pre-degenerated joint bone. In one embodimentof the systems and methods disclosed herein, condylar surfaces of therestored bone model 28″ are surface matched to the condylar surfaces ofthe implant model 34″. However, because the restored bone model 28″ maybe bone only and not reflect the presence of the cartilage that actuallyextends over the pre-degenerated condylar surfaces, the surface matchingof the modeled condylar surfaces may be adjusted to account forcartilage or proper spacing between the condylar surfaces of thecooperating actual physical implants (e.g., an actual physical femoralimplant and an actual physical tibia implant) used to restore the jointsuch that the actual physical condylar surfaces of the actual physicalcooperating implants will generally contact and interact in a mannersubstantially similar to the way the cartilage covered condylar surfacesof the pre-degenerated femur and tibia contacted and interacted.

Thus, in one embodiment, the implant model is modified or positionallyadjusted to achieve the proper spacing between the femur and tibiaimplants. To achieve the correct adjustment, an adjustment value tr maybe determined (see FIG. 1J [block 185]). In one embodiment, theadjustment value tr that is used to adjust the surface matching may bebased off of an analysis associated with cartilage thickness. In anotherembodiment, the adjustment value tr used to adjust the surface matchingmay be based off of an analysis of proper joint gap spacing, asdescribed above with respect to FIGS. 14E and 14F. Both of the methodsare discussed below in turn.

i. Determining Cartilage Thickness

The wm in FIG. 21A represents the cartilage thickness of the medialtibia meniscus, and the wl in FIG. 21B represents the cartilagethickness of the lateral tibia meniscus. In one embodiment, thecartilage thicknesses wl and wm are measured for tibia meniscus for boththe lateral and medial plateaus 760, 765 via the MRI slices depicted inFIGS. 21A and 21B. The measured thicknesses may be compared. If thecartilage loss is observed for the medial plateau 765, then the wl_(min)of lateral plateau 760 is selected as the minimum cartilage thickness.Similarly, if the lateral plateau 760 is damaged due to cartilage loss,then the wm_(min) of medial plateau 765 is selected as the minimumcartilage thickness. The minimum cartilage wr may be illustrated in theformula, wr=min (wm, wl). In one embodiment, for purposes of theadjustment to the tibia shape matching, the adjustment value tr may bemay be equal to the minimum cartilage value wr.

ii. Determining Joint Gap

In one embodiment, the joint gap is analyzed as discussed above withrespect to FIGS. 14E and 14F to determine the restored joint line gapGp3. In one embodiment, for purposes of the adjustment to the tibiashape matching, the adjustment value tr may be calculated as being halfof the value for Gp3, or in other words, tr=Gp3/2.

K. Determine Slope Vectors for Tibia Plateau

The slope vectors for the plateau of the tibia restored bone model 28″are determined (see FIG. 1J [block 186]), as will be discussed withrespect to FIGS. 22A and 22B. The sagittal view of FIGS. 22A and 22Bare, respectively, lateral and medial sagittal MRI views of the plateauof the tibia restored bone model 28″.

FIG. 22A shows the lateral tibial plateau 760 for establishing theanterior-posterior landmark references in the tibia plateau. FIG. 22Bshows the medial tibial plateau 765 for establishing theanterior-posterior landmark references in the tibia plateau. Theanterior-posterior references can apply to both the tibia restored bonemodel 28″, as can be understood from the MRI slices of FIGS. 22A and 22Band the tibial implant model 34″ of FIGS. 23A-23C.

As indicated in FIG. 22A, points P, Q represent the highest of theanterior and posterior portions of lateral plateau surface 760. Thedirection vector PQ in FIG. 22A represents the anterior-posterior slopeof the lateral plateau 760 of tibia restored bone model 28″.

As indicated in FIG. 22B, points R, S represent the highest of theanterior and posterior portions of medial plateau surface 765. Thedirection vector RS in FIG. 22B represents the anterior-posterior slopeof the medial plateau 765 of tibia restored bone model 28″. For thesevectors, it can be said that vector PQ is equal to vector t, vector RSis equal to vector z, and vector t is parallel to vector z orsubstantially parallel such that the acute angle between vectors z and tis less than five degrees.

L. Determine Slope Vectors for Tibia Implant

The of slope vectors for the plateau of the tibia implant model 34″ aredetermined (see FIG. 1J [block 187]), as will be discussed with respectto FIGS. 23A-23C. The same analogy described with respect to finding theslope vectors for the tibia plateaus of the tibia restored bone model28″ applies to the tibia implant model 34″ of FIGS. 23A-23C. FIGS.23A-23C are, respectively, two isometric views and a side view of thetibia implant model 34″. Because the tibia implant model 34″ is asymmetric design, the anterior-posterior slope in both the medial andlateral plateaus 775, 770 of the implant model 34″ are parallel to eachother. The information regarding direction vector t in the lateral sideand direction vector z in the medial side of tibia restored bone model28″ applies to the anterior-posterior slopes of tibia implant model 34″.In the case when vectors t and z are within a five degree difference, anaverage value is provided by α, where

$\alpha = {\frac{\overset{arrow}{PQ} + \overset{arrow}{RS}}{{\overset{arrow}{PQ} + \overset{arrow}{RS}}}.}$

FIGS. 23A-23C depict a left knee tibia implant model 34″. As can beunderstood from FIG. 23A, the plateaus 770, 775 of the tibia implantmodel 34″ are symmetrical as viewed normal to the plateaus. As indicatedin FIG. 23B, the lateral bearing surface 770 is quite close to being aflat surface as compared to the medial surface 775.

As shown in FIGS. 23B and 23C, the direction vector h represents theanterior-posterior slope of tibia implant model 34″. A process similarto that employed to determine the anterior-posterior slope for the tibiarestored bone model 28″ in FIGS. 22A and 22B, wherein the tibia plateauMRI slices were used to determine direction vectors t and z, can beapplied to the tibia implant model 34″ where vector h is parallel tovector z, which is parallel to vector t. Therefore, theanterior-posterior slope information for the lateral plateau can beobtained in tibia implant model 34″ in FIG. 23C.

The same analogy applies to the tibia implant model 34″ of the rightknee, where the implant is a symmetric design. The lateral surfaceprofile of a right knee tibia implant is close to a flat surface. Theanterior-posterior slope information for the lateral plateau of theplanning model of the right knee can apply to the lateral surfaceprofile of the tibial implant of the right knee.

M. Addressing Possible IR/ER Misalignment for the Tibial Implant

The possible IR/ER misalignment issue for the design of tibial implantmodel 34″ can be assessed (see FIG. 1J [block 188]), as depicted inFIGS. 24A and 24B, which are, respectively, a plan or top view of thetibia plateau and a side medial side view of the tibia restored bonemodel 28″. The medial plateau 765 of tibia restored bone model 28″ inFIGS. 24A and 24B shows the elliptical concavity 786. The directionvector m in FIG. 24B shows a rolling or sliding movement of the medialcondyle 445 of the femur restored bone model 28′. In FIG. 24A, thetangential line m along the medial plateau 765 of the tibia restoredbone model 28″ can be obtained. The elliptical shape 786 (shown indashed lines) in the medial plateau 765 is identified, as indicated inFIG. 24A. The major axis (i.e., vector m) of the ellipse 786 providesthe IR/ER alignment information to the location of tibial implant model34″.

The above described landmark references and the IR/ER alignment of thetibial restored bone model 28″ provides the proximity information of thelandmarks and IR/ER alignment to the tibial implant model 34″.

N. Modifying the Tibial Implant Model to Account for the AdjustmentValue tr

FIG. 25 is an isometric view of the tibia implant model 34″ as it iscompensated to account for the adjustment value tr, which depending onthe embodiment, may be a function of cartilage thickness or restoredjoint gap. As shown in FIG. 25, the tibia implant model 34″ can becompensated with respect to the adjustment value tr in the medial andlateral sides 775, 770 of the articular bearing member 785 of tibialimplant model 34″ (see FIG. 1J [block 189]).

The adjustment value tr may be determined via any of the above-describedembodiments. Having determined the adjustment value tr, the compensationof the tibial implant model 34″ for the adjustment value tr can beachieved by lowering the mid-portions of each tibial plateau 770, 775 afir distance. For example, the mid-portions of the medial side 775 willbe lowered to achieve the adjustment value tr. Similarly, themid-portions of the lateral side 770 of the articular bearing member 785will be lowered to achieve the adjustment value tr.

O. Surface Matching for Tibia Implant

FIG. 26 is an isometric view of the tibia implant model 34″ beingsurface matched relative to the tibia restored bone model 28″ (see FIG.1J [block 190]). As shown in FIG. 26, direct surface matching occursfrom the plateau surfaces 760, 765 of tibia bone restored bone model28″. The modeling of surface profiles 800, 805 of the lateral and medialplateau 770, 775 of the tibial implant model 34″ are based from each ofthe portions of lateral and medial plateau 760, 765 of tibia restoredbone model 28″, respectively.

For example, based on the surface profile q (x, y, z) of the medialplateau 765 of the restored bone model 28″, the surface profile 805(i.e., p (x, y, z)) of medial portion 775 of the implant model 34″ canbe obtained. The function e(x, y, z) represents a true vector assumingthat template noise is independent of the implant medial surface profilenoise. The problem is estimating the parameters of a 3D transformationwhich satisfies the least squares fit 3D surface matching of the tibialmedial surface profile 805 (i.e., p (x, y, z)) of the tibial implantmodel 34″ to the medial plateau surface profile q (x, y, z) of restoredbone model 28″. This can be achieved by minimizing a goal function,which measures the sum of squares of the Euclidean distances betweenthese two surface profiles, represented by e(x,y,z)=q(x,y,z)−p(x,y,z).

The same rationale applies to the surface profile modeling of thelateral compartment 800 of implant model 34″. Based on the surfaceprofile q′ (x, y, z) of lateral plateau 760 in restored bone model 28″,the surface profile 800 (i.e., p′ (x, y, z) of the lateral compartment770 of the implant model 34″ can be obtained. The e′(x, y, z) representsa true vector assuming that template noise is independent of the implantmedial surface profile noise. Again, the problem is estimating theparameters of a 3D transformation which satisfies the least squares fit3D surface matching the lateral surface profile 800 (i.e., p′ (x, y, z))of the tibial implant model 34″ to the lateral plateau surface profile q(x, y, z) of the tibial restored bone model 28″. This can be achieved byminimizing a goal function, which measures the sum of squares of theEuclidean distances between these two surface profiles, represented bye′(x,y,z)=q′(x,y,z)−p′(x,y,z). See D. Akca (supra).

Surface modeling, as described in the following discussion, can beutilized as an option to the surface matching process discussed withrespect to FIG. 26. FIGS. 27A and 27B are, respectively, medial andlateral sagittal MRI views of the tibia. FIG. 28 is an isometric view ofthe tibia restored bone model 28″ and tibia implant model 34″ being usedin the surface matching process.

FIG. 27A shows the elliptical concavity outline 810 in as viewed via amedial MRI slice. Each of the medial plateau MRI slices shows an ellipseshape in Area A of FIG. 20. The major axis and radius of the ellipse canbe obtained in FIGS. 24A and 24B. A 3D ellipsoid model 815 from medialtibia plateau 765 in FIG. 28 can then be reconstructed by computersoftware through a plurality of MRI slices similar to the MRI slicedepicted in FIG. 27A.

FIG. 27B shows the rectangle shape outline 820 in a lateral MRI slice.Each of the lateral plateau MRI slices shows a rectangle shape 820 inArea B of FIG. 20. The 3D rectangle block model 825 from the lateraltibia plateau 760 in FIG. 28 can then be reconstructed by computersoftware through a plurality of MRI slices similar to the MRI slicedepicted in FIG. 27B.

FIG. 28 shows a representation of 3D surface matching that can beemployed with the process discussed with respect to FIGS. 27A and 27B.As described above, the ellipsoid model 815 is reconstructed from themedial plateau MRI slices. The surface profile of this ellipsoid model815 can be represented as k(x,y,z). The medial concavity 830 matches theellipsoid model 815.

The surface profile 805 (i.e., p(x,y,z)), representing the medialcompartment 775 of the articular bearing member 785, can be obtainedeither through the surface profile of the ellipsoid model 815 or themedial concavity 830 of the tibial restored bone model 28″, as shown inFIG. 28. The function e(x, y, z) represents a true vector assuming thattemplate noise is independent of the implant surface profile noise. Thepathmeters of a 3D transformation satisfy the least squares fit 3Dsurface matching so as to match the surface profile 805 (i.e., p (x, y,z)) of the medial compartment 775 to the surface profile k (x, y, z) ofellipsoid model 815. This can be achieved by minimizing a goal function,which measures the sum of squares of the Euclidean distances betweenthese two surface profiles, represented by e(x,y,z)=k(x,y,z)−p(x,y,z).See D. Akca (supra).

The rectangle block model 825 is reconstructed from the lateral plateauMRI slices. The surface profile of this rectangle block model 825 can berepresented as k′(x,y,z). The lateral concavity 835 matches therectangle block model 825. In one embodiment, the surface profile 800(i.e., p′(x,y,z)), representing the lateral compartment 760 of thearticular bearing member 785, can be obtained either through the surfaceprofile of the rectangle block model 825 or the lateral concavity 835 ofthe tibial restored bone model 28″ as shown in FIG. 28. The functione′(x, y, z) represents a true vector assuming that template noise isindependent of the implant surface profile noise. The parameters of a 3Dtransformation satisfy the least squares fit 3D surface matching thesurface profile 800 (i.e., p′ (x, y, z)) of the lateral compartment 760to the surface profile k′ (x, y, z) of rectangle block model 825. Thiscan be achieved by minimizing a goal function, which measures the sum ofsquares of the Euclidean distances between these two surface profiles,represented by e′(x,y,z)=k′(x,y,z)−p′(x,y,z). See D. Akca (supra).

P. Determining Surgical Cut Plane for Tibia

FIG. 29A is an isometric view of the tibia restored bone model 28″showing the surgical cut plane SCP design. FIGS. 29B and 29C aresagittal MRI views of the surgical tibia cut plane SCP design with thePCL.

As can be understood from FIGS. 29A-29C, the surgical cut plane SCP 850is designed in the tibial planning model of the POP procedure. Duringthe TKA surgery, the damaged bone surface portions of the proximal tibiawill be resected from the cut plane level 850 and be removed by thesurgeon. As shown in FIGS. 29B and 29C, the surgical tibial cut plane850 may be positioned above the surface where PCL is attached.Therefore, the system disclosed herein provides the maintenance of thePCL ligament during TKA surgery. In the POP planning, if the cut planeis below the surface plane of PCL, the revaluation of the tibial implantsize is conducted. In such a case, a one-size smaller implant isselected for the implant model design.

In a manner similar to that depicted in FIG. 19B, when the tibia implantmodel 34″, which was modified according to the adjustment value tr asindicated in FIG. 25, is shape fit to the tibia restored bone model 28″,the surgical cut plane SCP (see FIG. 23C) ends up being locatedproximally further by the amount of the adjustment value tr than itwould otherwise be, resulting in the actual physical implant whenmounted on the actual proximal tibia end providing articular surfacesthat are positioned and oriented so as to allow the patient's knee toassume a natural or non-degenerated configuration.

The orientation and location of the implant's mounting post 780 may alsobe determined once the implant model 34″ and restored bone model 28″ aresuperposed. Also, the locations and orientations of the drill holes 124(see FIGS. 1H and 1I) of the arthroplasty jig 2A may be determined fromthe implant model 34″ and restored bone model 28″ being superposed.

Once the shape match process (see FIG. 1J [block 195] and FIG. 1C [block120]) is complete, the information regarding the locations andorientations for the saw cut slot 123 and drill holes 124 may bepackaged as saw cut and drill hole data 44 (see FIG. 1E [block 125]) andthe process goes forward as outlined in FIG. 1E.

R. Verification of Implant Planning Models and Generation of SurgicalJigs Based of Planning Model Information

FIGS. 30A-30C are various views of the implant models 34′, 34″superimposed on the bone models 28′, 28″. FIG. 30D is a coronal view ofthe restored bone models 28′, 28″.

FIGS. 30A-30C show an embodiment of the POP system disclosed herein. Thealignment of the implants models 34′, 34″ with the restored bone models28′, 28″ is checked in both the anterior view (FIG. 30A) and theposterior view (not shown) and the lateral view (FIG. 30B) and themedial view (FIG. 30C).

The IR/ER rotation between the implants 34′, 34″ and the femur and tibiarestored bone models 28′, 28″ is examined in both the medial view andthe lateral view. For example, FIG. 30B shows the lateral view showingthe IR/ER rotation between no flexion and high flexion, and FIG. 30Cshows the medial view showing the IR/ER rotation between no flexion andhigh flexion. The stem of the tibia implant model 34″ and the surgicalcut plane SCP of the tibia implant model 34″ provide the information forthe IR/ER rotation.

FIG. 30D shows the varus/valgus alignment of the knee model 28′, 28″with the absence of the implants 34′, 34″. The gaps g1, g2 between thelowermost portions of distal femoral condyles 430, 445 and the lowermostportions of the tibia plateau 760, 765 will be measured in the femoraland tibia restored bone models 28′, 28″. Gap g1 represents the distancebetween the distal lateral femoral condyle 430 and the lateral tibialplateau 760. Gap g2 represents distance between the distal medialfemoral condyle 445 and the medial tibial plateau 765. In thevarus/valgus rotation and alignment, g1 is substantially equal to g2, or|g1−g2|<<1 mm.

FIG. 30D shows the knee model 28′, 28″ that is intended to restore thepatient's knee back to his pre-OA stage. The knee model 28′, 28″ andassociated implant models 34′, 34″ developed through the above-discussedprocesses include dimensions, features and orientations that the system4 depicted in FIG. 1A can utilize to generate 3D models of femur andtibia cutting jigs 2. The 3D model information regarding the cuttingjigs can the be provided to a CNC machine 10 to machine the jigs 2 froma polymer or other material.

S. Mechanical Axis Alignment

While much of the preceding disclosure is provided in the context ofachieving natural alignment for the patient's knee post implantation ofthe actual physical femur and tibia implants, it should be noted thatthe systems and methods disclosed herein can be readily modified toproduce an arthroplasty jig 2 that would achieve a zero degreemechanical axis alignment for the patient's knee post implantation.

For example, in one embodiment, the surgeon utilizes a natural alignmentfemoral arthroplasty jig 2A as depicted in FIGS. 1F and 1G to completethe first distal resection in the patient's femoral condylar region.Instead of utilizing a natural alignment tibia arthroplasty jig 2B asdepicted in FIGS. 1H and 1I, the surgeon instead completes the firstproximal resection in the patient's tibia plateau region via free handor a mechanical axis guide to cause the patient's tibia implant toresult in a mechanical axis alignment or an alignment based off of themechanical axis (e.g., an alignment that is approximately one toapproximately three degrees varus or valgus relative to zero degreemechanical axis).

In one embodiment, as indicated in FIGS. 31A-32B, the arthroplasty jigs2AM and 2BM may be configured to provide bone resections that lead tonatural alignment, mechanical axis alignment or alignments in betweenthe two. For example, the jigs 2AM and 2BM may have a natural alignmentsaw slot 123 and one or more non-natural alignment saw slots 123′, 123″and 123′ that may, for example, be one degree, two degrees, threedegrees or some other incremental measurement away from naturalalignment and towards zero degree mechanical axis alignment. The surgeonmay select a two degree deviation slot 123″ based on a physicalinspection and surgical experience.

In one embodiment of the POP systems and methods disclosed herein,instead of superposing and shape matching the restored bone models 28′,28″ to the implant models 34′, 34″ in a manner that results in the sawcut and drill hole data 44 that leads to the production of naturalalignment arthroplasty jigs 2A, 2B, the superposing and shape matchingof the bone and implant models 28, 34 may be conducted such that theresulting saw cut and drill hole data 44 leads to the production of zerodegree mechanical axis alignment arthroplasty jigs or some other type ofarthroplasty jig deviating in a desired manner from zero degreemechanical axis.

Thus, depending on the type of arthroplasty jig desired, the systems andmethods disclosed herein may be applied to both the production ofnatural alignment arthroplasty jigs, zero degree mechanical axisalignment jigs, or arthroplasty jigs configured to provide a result thatis somewhere between natural alignment and zero degree mechanical axisalignment.

Although the present invention has been described with reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A method of manufacturing an arthroplasty jig,the method comprising: a.) generate a restored bone model, wherein thebone model includes a three dimensional computer model of at least aportion of a joint surface of a bone of a patient joint to undergo anarthroplasty procedure, wherein the restored bone model isrepresentative of the bone in a pre-degenerated state; b.) generate animplant model, wherein the implant model includes a three dimensionalcomputer model of at least a portion of a joint surface of anarthroplasty implant to be used in the arthroplasty procedure; and c.)shape match an articular joint surface of the restored bone model and acorresponding articular joint surface of the implant model.
 2. Themethod of claim 1, further comprising determining at least one of alocation and orientation of a surgical cut plane relative to the implantmodel, wherein the surgical cut plane is associated with the implantmodel.
 3. The method of claim 2, wherein the surgical cut planecorresponds to a proximal resection to be made in the bone of thepatient, wherein the bone is a tibia.
 4. The method of claim 1, whereinthe arthroplasty implant is at least one of a TKR or partial kneeimplant.
 5. The method of claim 1, wherein the patient joint is at leastone of an ankle, knee, hip, wrist, elbow, shoulder, vertebra-vertebrainterface, vertebra-sacrum interface, and vertebra-skull interface. 6.The method of claim 1, wherein the bone is at least one of a femur andtibia.
 7. A method of manufacturing an arthroplasty jig, the methodcomprising: a.) generate two-dimensional images of a joint surface of apatient bone; b.) generate first data from the two-dimensional images,wherein the first data is representative of the joint surface in adeteriorated state; c.) generate second data from the two-dimensionalimages, wherein the second data is representative of the joint surfacein a non-deteriorated state; d.) generate third data and fourth datapositionally referenced to the third data, wherein the third data isrepresentative of a joint surface of an arthroplasty implant and thefourth data is representative of a surgical cut plane associated withthe arthroplasty implant; e.) generate fifth data from the first data,wherein the fifth data is representative of a surface of thearthroplasty jig that will matingly receive the joint surface; f.)generate sixth data by matching the second data and the third data, theresulting sixth data including a position of the fourth data when thesecond and third data are matched; g.) generate seventh data by mergingthe fifth data and the sixth data; and h.) employ the seventh data inmanufacturing the arthroplasty jig from a jig blank.
 8. The method ofclaim 7, wherein the two-dimensional images are at least one of MRI andCT.
 9. The method of claim 7, wherein the first data includes athree-dimensional computer generated arthritic bone model.
 10. Themethod of claim 7, wherein the first data includes a three-dimensionalcomputer generate surface model.
 11. The method of claim 7, wherein thesecond data includes a three-dimensional computer generated restoredbone model.
 12. The method of claim 7, wherein the second data includesa three-dimensional computer generated volume model.
 13. The method ofclaim 7, wherein the third and fourth data are associated with athree-dimensional computer generated model of the arthroplasty implant.14. The method of claim 7, wherein the second data includes athree-dimensional computer generated volume model, the third includes ajoint surface of a three-dimensional computer generated model of thearthroplasty implant, and the sixth data is generated by surfacematching a joint surface of the volume model and the joint surface ofthe model of the arthroplasty implant.
 15. The method of claim 7,wherein the second data is positionally referenced to the first data andat least some of the data respectively resulting from the first andsecond data is similarly positionally referenced.
 16. The method ofclaim 15, wherein the fifth and sixth data are positionally referencedto each other to facilitate their merging.
 17. The method of claim 7,wherein the seventh data is used to generate automated manufacturinginstructions employed by an automated manufacturing machine used tomanufacture the arthroplasty jig from the jig blank.
 18. The method ofclaim 17, wherein the automated manufacturing machine is at least one ofa CNC machine and a SLA machine.
 19. The method of claim 7, wherein thesurgical cut plane corresponds to a distal resection to be made in thepatient bone, wherein the patient bone is a femur.
 20. The method ofclaim 7, wherein the surgical cut plane corresponds to a proximalresection to be made in the patient bone, wherein the patient bone is atibia.
 21. The method of claim 7, wherein the arthroplasty implant is atleast one of a TKR or partial knee implant.
 22. The method of claim 7,wherein the patient bone is at least one of a femur and tibia.
 23. Themethod of claim 7, wherein the joint surface of the patient boneincludes a condyle articular surface.
 24. The method of claim 23,wherein the joint surface of the arthroplasty implant includes a condylearticular surface.